respironics recall registration

The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. Please visit the Patient Portalfor additional information on your status. %%EOF Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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 Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. Eight of those reports were from the U.S. 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). No. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. ) or https:// means youve safely connected to 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. Koninklijke Philips N.V., 2004 - 2023. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The devices are used to help breathing. Use another similar device that is not a part of this recall. The data collected will be used to help to prioritize remediation of those patients at higher risk. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. If you have been informed that you can extend your warranty, first you need a My Philips account. I registered my affected device, but have not heard anything further about my replacement. VA clinical experts are working with the FDA and the manufacturer to understand those risks. 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. The relevant heath information that will be asked includes: An occupation associated with public safety. Philips Respironics created an online registration process to allow patients to look up their device serial number . 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. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. 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 The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. We may request contact information, date of birth, device prescription or physician information. 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. 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. Log in Once you've registered your device, please remember to save your confirmation number which will be emailed to you. CHEST MEMBERSHIP About Membership . Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. 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. 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. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Questions regarding registration, updating contact information (including address), or to cancel a registration. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. 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. 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. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. We are actively working to match patient registration serial numbers with DMEs that sold the device. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The FDA's evaluation of the information provided by Philips is ongoing. Creating a plan to repair or replace recalled devices. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. We may request contact information, date of birth, device prescription or physician information. The .gov means its official.Federal government websites often end in .gov or .mil. Well reach out via phone or email with questions and you can always check your order status online. Philips Respironics has issued a . You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Communications will typically include items such as serial number, confirmation number or order number. 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. You can still register your device on DreamMapper to view your therapy data. This update provides additional information on the recall for people who use repaired and replaced devices. 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. Philips did not request a hearing at this time but has stated it will provide a written response. Trying to or successfully removing the foam may damage the device or change how the device works. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Polyester-Based polyurethane ( PE-PUR ) foam used in these devices to reduce sound and vibration can break down to! 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