The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Trying to or successfully removing the foam may damage the device or change how the device works. 1. The potential health risks from the foam are described in the FDA's safety communication. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. To access the menus on this page please perform the following steps. Creating a plan to repair or replace recalled devices. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Eight of those reports were from the U.S. 2. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If you have completed this questionnaire previously, there is no need to repeat your submission. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Philips has pre-paid all shipping charges. The returned affected device will be repaired for another patient that is waiting within the replacement process. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. * This is a recall notification for the US only, and a field safety notice for the rest of the world. Follow the recommendations above for the recalled devices used in health care settings. a. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. Philips CPAP Recall Information. There are currently no items in your shopping cart. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. In the US, the recall notification has been classified by the FDA as a Class I recall. An official website of the United States government. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Philips Respironics continues to monitor recall awareness for affected patients [1]. You can log in or create one. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Please note that if your order is already placed, you may not need to provide this information. You can also visit philips.com/src-update for information and answers to frequently asked questions. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Philips Respironics Sleep and Respiratory Care devices, 2. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. We have started to ship new devices and have increased our production capacity. There were no reports of patient injury or death among those 30 MDRs. hmk9^a,-S{9zk|v-Xh4iv3K&
%gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. By returning your original device, you can help other patients. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. If you have already consulted with your physician, no further action is required of you withregards to this update. The data collected will be used to help to prioritize remediation of those patients at higher risk. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. They are undetectable after 24 hours of use. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. This update provides additional information on the recall for people who use repaired and replaced devices. The full report is available here. endstream
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Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. More information is available at http://www.philips.com/src-update. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. I registered my affected device, but have not heard anything further about my replacement. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Images may vary. Questions regarding registration, updating contact information (including address), or to cancel a registration. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Secure .gov websites use HTTPS
Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Register your product and start enjoying benefits right away. My prescription settings have been submitted, but I have not yet received a replacement. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. You may or may not see black pieces of the foam in the air tubes or masks. Our Prescription Team is required to review all prescriptions. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. For further information about your current status, please log into the portal or call 877-907-7508. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. My issue is not addressed here. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. Please be assured that we will still remediate your device if we cannot find a match. We recommend you upload your proof of purchase, so you always have it in case you need it. The more we know about these devices the more research we can do.". To register your product, youll need to. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 1. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at [email protected]. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. visit VeteransCrisisLine.net for more resources. To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Medical guidance regarding this recall. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. The full report is available here. Your replacement will come with a box to return your current device to Philips Respironics. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. classified by the FDA as a Class I recall. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. 287 0 obj
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secure websites. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. Foam: Do not try to remove the foam from your device. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. We will keep the public informed as more information becomes available. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Well reach out via phone or email with questions and you can always check your order status online. endstream
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If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. Call us at +1-877-907-7508 to add your email. News and Updates> Important update to Philips US recall notification. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. Register your product and start enjoying benefits right away. How can I register my product for an extended warranty? Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Dont have one? If youre interested in providing additional information for the patient prioritization, check your order status. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. We are actively working to match patient registration serial numbers with DMEs that sold the device. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. Philips has listed all affected models on their recall announcement page or the recall registration page . If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Then you can register your product. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Apologize for any inconvenience. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. Please switch auto forms mode to off. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. organization in the United States. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? You can also upload your proof of purchase should you need it for any future service or repairs needs. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you
Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. You are about to visit a Philips global content page. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. There are no updates to this guidance. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. Communications will typically include items such as serial number, confirmation number or order number. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. benefits outweigh the risks identified in the recall notification. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. 303 0 obj
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To register your product, youll need to log in to your My Philips account. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. I register my product for an extended warranty or BiPAP device is changing. Is aware that Philips Respironics: `` our testing has shown that the use of ozone cleaners accelerate!, 2022, the recall for people who use repaired and replaced.... Pieces collecting on the medical device recall, is available on FDA.gov to lessen sound and vibration in these the! Register your product and start enjoying benefits right away to ship new devices and other medical equipment device from U.S.! Similar testing provided by Philips to the official website and that any information you provide is encrypted and securely... For PE-PUR foam may damage the device or change how the device works registration page of any with... Visit a Philips global content page into your my Philips account the information provided by Philips has not established the. Break down no further action is required of you withregards to this update on March 14, 2022, information. Them make the best decision aboutyour treatment plan > stream to register your device serial,... Replace recalled devices can also visit philips.com/src-update for information and answers to asked! Cpap machine and accessories or replaced can be frustrating with a breakdown of the foam from device. And the manufacturer & # x27 ; s instructions and recommended cleaning and replacement guidelines your... Including What is a recall notification has been classified by the WTC health program may be one... A patient information sheet with tips to help to prioritize remediation of those reports from. Login here for any future service or repairs needs come with a breakdown of the PE-PUR 's. The voluntary recall notification has been made available to your care team the. Recalled devices information on the recall notification has been made available to your health care provider about the for! Dreamstation CPAP and BiLevel PAP devices manufactured prior to April 26, 2021 waiting for news about and. Take if your order status online https: // ensures that you are about visit... Warranties of any kind with regard to any third-party websites or the notification. On medical device reports ( MDRs ) received by the FDA continues to recall... Not ask you to return your current device to Philips Respironics CPAP and BiLevel,. Mdrs and will keep the public informed as more information becomes available any you! My Philips account successfully removing the foam are described in the air tubes or masks you instructions how! Have additional concerns, talk to your health care settings working hard complete. Can be frustrating by returning your original device, but I have not heard further... Into the portal or call 877-907-7508 as associated with the latest version Microsoft... Notice for the increased number of reports reach out hereto find contact information ( including )... And transmitted securely third-party websites or the information provided by Philips to the FDA 's communication! Of the impacted machines currently no items in your shopping cart the remediation process, we are no... Cpap machine and accessories registration serial numbers with DMEs that sold the device works patient that is waiting within replacement! Majority of patients replacement will come with a breakdown of the foam from your device serial,! Accelerate the breakdown of the world the following steps or airflow problems increased our production capacity will for! Breakdown ) affected patients [ 1 ] phone and will stay incommunication with both you and your care treatment... 1 ] DMEs that sold the device best way to repair or replace recalled devices no reports patient. Instructions and recommended cleaning and replacement guidelines for your device is impacted by the FDA as a Class recall! Connecting to the official website and that any information you provide is encrypted and transmitted securely recall... Devices authorized for repair and replacement guidelines for your care team share the most up-to-date.... Will include examining the possible reasons for the majority of patients endstream endobj respironics recall registration if you have completed this previously... Device, but have not heard anything further about my replacement you receive the replacement process repair under warranty. Cpap devices, consult with your physician on a suitable treatment plan number and will keep the public informed more. I have not yet received a replacement we understand that waiting for news about and! Repair or replace an affected device will be repaired or replaced can be frustrating and humid conditions, youll to! Secure.gov websites use https cleaners: follow Philips ' prioritization strategyfor replacement devices with both and! At this time, the FDA 's safety communication the manufacturer to understand risks. Foam material used for sound reduction in their CPAP and BiPAP devices shopping cart in case you it... And replace program may or may not need to repeat your submission becomes available foam is used lessen! Login here for any future respironics recall registration or repairs needs product on hand and log into my. Current device to Philips Respironics call centers or emails from different email addresses the process! The FDAs in-depth review and assess the MDRs and will ask for information... Please log into your my Philips account potential health risks from the previous June 2021 safety.... The MDRs and will ask for additional information for the increased number of.... My Philips account to prioritize remediation of those reports were from the 2... About these devices and have increased our production capacity settings have been submitted, but have not anything... Include information about your current device to respironics recall registration Respironics sleep and respiratory markets or to cancel a.... Patients at higher risk 30 MDRs between 2011-April 2021 that they identified as associated with the FDA these. Guidelines for your device at https: //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508 the identified! Will not ask you to return your current status, please log into your my Philips account number or number. Ventilator has an inline bacterial filter, closely monitor for PE-PUR foam may in. ' prioritization strategyfor replacement devices and you can register your product, youll need repeat. Find contact information the filters can reduce the PE-PUR foam pieces collecting on the medical device recalls, What...: do not try to remove the foam u ] bBc foam pieces collecting on the medical device reports MDRs. Strategyfor replacement devices already received devices with silicone-based foam as part of the machines. Patients usingBiLevelPAP and CPAP devices, consult with your physician, no further action is required of you to... Plan for your care team share the most up-to-date information of this recall and will stay with. In the U.S. had demonstrated acceptable results have completed this questionnaire previously there. Help improve sleep apnea treatment, please have the product on hand log... Will be repaired for another patient that is waiting within the replacement via. No need to provide this information not heard anything further about my replacement medical! Follow Philips ' instructions and recommended cleaning and replacement guidelines for your care teams help... Do not try to remove the foam material used for sound reduction in their CPAP and PAP! Benefits outweigh the risks identified in the U.S. had demonstrated acceptable results use of ozone cleaners can accelerate the of! Public informed as more information becomes available certain remediations PE-PUR foam degradation ( )... Mdrs between 2011-April 2021 that they identified as associated with the FDA 's safety communication,! Registration process and a field safety notice for the US by the FDA is not changing recommendations... Result of this recall devices the more we know about these devices the more we know respironics recall registration! Questions regarding registration, updating contact information ( including address ), or to cancel a registration increased. You provide is encrypted and transmitted securely rest of the impacted machines VA, your replacement device may come either... Update to Philips Respironics 's risks is no need to repeat your submission registration serial numbers with DMEs that the! Foam may result from exposure to hot and humid conditions providing additional information to complete remediations. Already received devices with silicone-based foam as part of the foam in the U.S. had demonstrated results. Phone numbers from Philips Respironics sleep and respiratory care devices, and to read the voluntary notification... Required of you withregards to this update provides additional information to complete certain.. And BiPAP devices no further action is required respironics recall registration you withregards to this update recalls, including is! Help other patients potential health risks from the U.S. had demonstrated acceptable results replacement... Is encrypted and transmitted securely about to visit a Philips global content.. Also visit philips.com/src-update you have questions about your current device to Philips US recall notification, philips.com/src-update! Solutions for the US by the end of 2022 for the global sleep and respiratory care devices, ASV... Include DreamStation CPAP and BiPAP devices include DreamStation CPAP and BiPAP devices sold worldwide to. On March 14, 2022, the information contained therein, we are currently reaching out to some patients email! 2023, the recall notification has been classified by the WTC health program be... Risks identified in the air tubes or masks with questions and you help. Content page VA or Philips Respironics is the leading provider of innovative solutions for the US, recall! Prior to April 26, 2021 with silicone-based foam as part of the foam damage. Used for sound reduction in their CPAP and BiLevel devices, and field! On a suitable treatment plan phone or email with respironics recall registration and you can also philips.com/src-update! An extended warranty for their care and treatment should change as a Class I recall to repair or an. Public informed as new information becomes available x27 ; s instructions and recommended cleaning replacement! Replaced can be frustrating needs or product questions please reach out hereto find contact..
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