If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. The returned affected device will be repaired for another patient that is waiting within the replacement process. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. My prescription settings have been submitted, but I have not yet received a replacement. Philips Respironics has issued a . For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Call us at +1-877-907-7508 to add your email. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Cleaning, setup and return instructions can be found here. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. The potential health risks from the foam are described in the FDA's safety communication. 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. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. You can view a list of all current product issues and notifications by visiting the link. The foam cannot be removed without damaging the device. 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. have hearing loss. Well reach out via phone or email with questions and you can always check your order status online. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. Koninklijke Philips N.V., 2004 - 2023. How can I register my product for an extended warranty? 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. the .gov website. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. News and Updates> Important update to Philips US recall notification. ) or https:// means youve safely connected to Please check the Patient Portal for updates. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 303 0 obj <>stream You can also upload your proof of purchase should you need it for any future service or repairs needs. The full report is available here. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. You can also upload your proof of purchase should you need it for any future service or repairs needs. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + 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. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. No. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. An official website of the United States government. 2. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. 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. 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. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Can we help? 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 portal to register your recalled device: REGISTER MY DEVICE . Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. If youre interested in providing additional information for the patient prioritization, check your order status. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. 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/ Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. No. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. We will automatically match your registered device serial number back to our partner inventory registrations. 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 It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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 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. 2. 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. 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. 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. Share sensitive information only on official, If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Didn't include your email during registration? Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Information you provide is encrypted and transmitted securely '' ) website described in the Recall my! 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