You can still register your device on DreamMapper to view your therapy data. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Philips has listed all affected models on their recall announcement page or the recall registration page. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream organization in the United States. The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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. 22 Questions 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. 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. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. kidneys and liver) and carcinogenic effects. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. First, determine if you are using one of the affected devices. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. To enter and activate the submenu links, hit the down arrow. 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? Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 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). You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Veterans Crisis Line: We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Is there a question we can answer for you? Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. You must register your recalled device to get a new replacement device. You can create one here. For any therapy support needs or product questions please reach out hereto find contact information. You may have to contact your care provider to program the device to your prescribed settings. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Well reach out via phone or email with questions and you can always check your order status online. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. Please be assured that we will still remediate your device if we cannot find a match. Create account Create an account Already have an account? Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. I have received my replacement device and have questions about setup and/or usage. 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. Repairing and replacing the recalled devices. Determining the number of devices in use and in distribution. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. No. We recommend you upload your proof of purchase, so you always have it in case you need it. You can create one here. Philips has pre-paid all shipping charges. You can log in or create one. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. For more information of the potential health risks identified, see the FDA Safety Communication. To register your product, youll need to log in to your My Philips account. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. 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. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Entering your device's serial number during registration will tell you if it is one of the. 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. 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. To register your product, youll need to. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Communications will typically include items such as serial number, confirmation number or order number. classified by the FDA as a Class I recall. The foam cannot be removed without damaging the device. Share sensitive information only on official, By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. All rights reserved. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. If youre interested in providing additional information for the patient prioritization, check your order status. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Register your product and start enjoying benefits right away. CHEST MEMBERSHIP About Membership . Secure .gov websites use HTTPS To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. Then you can register your product. For Spanish translation, press 2; Para espaol, oprima 2. a. All rights reserved. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. The full report is available here. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. To register a new purchase, please have the product on hand and log into your My Philips account. You are about to visit a Philips global content page. I am experiencing technical issues with the Patient Portal. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 3. 2. For further information about your current status, please log in to the. If you have completed this questionnaire previously, there is no need to repeat your submission. You may or may not see black pieces of the foam in the air tubes or masks. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. We may request contact information, date of birth, device prescription or physician information. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. An official website of the United States government. You can also visit philips.com/src-update for information and answers to frequently asked questions. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. We will keep the public informed as more information becomes available. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Trying to or successfully removing the foam may damage the device or change how the device works. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Keep your registration confirmation number. For further information, and to read the voluntary recall notification, visit philips.com/src-update. The relevant heath information that will be asked includes: An occupation associated with public safety. 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. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. Register your product and start enjoying benefits right away. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips CPAP Recall Information. 1. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. If you do not find your device on the list, then it has not been recalled and you should continue to use it. To date there have been no reports of death from exposure to the recalled devices. More information is available at http://www.philips.com/src-update. Consult with your physician as soon as possible to determineappropriate next steps. The returned affected device will be repaired for another patient that is waiting within the replacement process. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Please check the Patient Portal for updates. 2. What information do I need to provide to register a product? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. I have received my replacement device and would like to report a quality issue. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . To register by phone or for help with registration, call Philips at 877-907-7508. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. You can log in or create one here. We are investigating potential injury risks to users, including several cancers. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. We have started to ship new devices and have increased our production capacity. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. If you use one of these recalled devices, follow the recommendations listed below. There are currently no items in your shopping cart. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. If youre interested in providing additional information for the patient prioritization, check your order status. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. The .gov means its official.Federal government websites often end in .gov or .mil. Surgical options, including removing sinus tissue or realigning the jaw. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. 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. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. have hearing loss. Koninklijke Philips N.V., 2004 - 2023. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. VA clinical experts are working with the FDA and the manufacturer to understand those risks. The FDA's evaluation of the information provided by Philips is ongoing. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. See the FDA Safety Communication for more information. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. Recommend you upload your proof of purchase is a medical device recalls, including what is a device. Sinus tissue or realigning the jaw make available more BiPAP and CPAP devices, the! Questions please reach out hereto find contact information your item or a pdf document from an shop... Questions please reach out hereto find contact information to return your recalled device to get new. 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