You are about to visit a Philips global content page. To register your product, youll need to. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. The site is secure. The returned affected device will be repaired for another patient that is waiting within the replacement process. By returning your original device, you can help other patients. 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. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Lifestyle Measures to Manage Sleep Apnea fact sheet. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. For patients using life-sustaining ventilation, continue prescribed therapy. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Entering your device's serial number during registration will tell you if it is one of the. 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. 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. Membership & Community. 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. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. VA clinical experts are working with the FDA and the manufacturer to understand those risks. 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. You are about to visit the Philips USA website. You can log in or create one. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. A locked padlock Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. The relevant heath information that will be asked includes: 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. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. 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. 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. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. The full report is available here. 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. classified by the FDA as a Class I recall. 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. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Devices need to be registered with Philips Respironics to receive a replacement device. Lock The FDA's evaluation of the information provided by Philips is ongoing. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Very small particles from the foam could break lose and come through the air hose. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + 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. My issue is not addressed here. Be aware that during the 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 certain chemicals of concern, called volatile organic compounds (VOCs). 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. Philips Respironics has issued a . Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. Be cautious as they may be scams! Steps to return your affected device: By returning your original device, you can help other patients. Philips CPAP Recall Information. Secure .gov websites use HTTPS 2. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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. You can still register your device on DreamMapper to view your therapy data. See the FDA Safety Communication for more information. kidneys and liver) and carcinogenic effects. The FDA recognizes that many patients have questions about what this information means for the status of their devices. Creating a plan to repair or replace recalled devices. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. 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. Please note that if your order is already placed, you may not need to provide this information. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. 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. A .gov website belongs to an official government Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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 more we know about these devices the more research we can do.". Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. More information on. 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. 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. 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. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . 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. Communications will typically include items such as serial number, confirmation number or order number. You can also upload your proof of purchase should you need it for any future service or repairs needs. Didn't include your email during registration? At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. 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. I received a call or email from someone claiming to be from Philips Respironics. 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. b. To access the menus on this page please perform the following steps. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. No. What information do I need to provide to register a product? 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 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. Learn more at www.vcf.gov . Only clean your device according to the manufacturers recommendations. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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). 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. 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