CDRH will consider the response when it is received. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. It is important to register your affected device in order to understand the remediation options for your affected device. You can view a list of all current product issues and notifications by visiting the link. Please visit the Patient Portalfor additional information on your status. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. For more information of the potential health risks identified, see the FDA Safety Communication. 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 You can also upload your proof of purchase should you need it for any future service or repairs needs. You can create one here. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Philips Respironics (Philips) voluntarily recalledcertain 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. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. You are about to visit the Philips USA website. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. 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. Philips Respironics continues to monitor recall awareness for affected patients [1]. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. A locked padlock 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? Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. 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. Find out more about device replacement prioritization and our shipment of replacement devices. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. 2. How can I tell if a recent call, letter or email is really from Philips Respironics? In the US, the recall notification has been. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). There are no updates to this guidance. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Once your order is placed the order number will be listed in the Patient Portal. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. No. 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). 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. Register your product and start enjoying benefits right away. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. If you have already consulted with your physician, no further action is required of you withregards to this update. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. To register your product, youll need to log in to your My Philips account. Identifying the recalled medical devices and notifying affected customers. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Membership. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Selected products The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. How can I register my product for an extended warranty? 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. If you use one of these recalled devices, follow the recommendations listed below. have hearing loss. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. There were no reports of patient injury or death among those 30 MDRs. The DME supplier can check to see if your device has been recalled. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. 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. That will allow them place an order for your supplies. 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. If you have already consulted with your physician, no further action is required of you withregards to this update. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. For Spanish translation, press 2; Para espaol, oprima 2. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 2. 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. 2. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). kidneys and liver) and carcinogenic effects. Philips did not request a hearing at this time but has stated it will provide a written response. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. 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. 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. The site is secure. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 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. I would like to learn more about my replacement device. 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. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. Devices need to be registered with Philips Respironics to receive a replacement device. All rights reserved. All rights reserved. benefits outweigh the risks identified in the recall notification. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. The site is secure. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Please switch auto forms mode to off. 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. Creating a plan to repair or replace recalled devices. Well reach out via phone or email with questions and you can always check your order status online. You can also visit philips.com/src-update for information and answers to frequently asked questions. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Please remember to save your confirmation number which will be leaving the official Royal Philips Healthcare ( Philips., stopping use of the repair and replace program similar device that is part! Tubes and be inhaled or swallowed by the user assess MDRs and will you... Class I recall, is available on FDA.gov would like to learn more about device prioritization! Or email with questions and you can also visit philips.com/src-update to stop therapy before consulting withyour physician for CPAP! 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