respironics recall registration

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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. There are currently no items in your shopping cart. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 2. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. Philips Respironics Sleep and Respiratory Care devices, 2. 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. To register your product, youll need to. 272 0 obj <> endobj Why do I need to upload a proof of purchase? *. 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. Register your product and start enjoying benefits right away. The full report is available here. Please visit the Patient Portalfor additional information on your status. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. You can still register your device on DreamMapper to view your therapy data. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. * This is a recall notification for the US only, and a field safety notice for the rest of the world. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. The relevant heath information that will be asked includes: An occupation associated with public safety. 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. 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: . . We may request contact information, date of birth, device prescription or physician information. First, determine if you are using one of the affected devices. Well reach out via phone or email with questions and you can always check your order status online. The DME supplier can check to see if your device has been recalled. 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. You may have to contact your care provider to program the device to your prescribed settings. 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. Consult with your physician as soon as possible to determineappropriate next steps. You may or may not see black pieces of the foam in the air tubes or masks. More information is available at http://www.philips.com/src-update. The returned affected device will be repaired for another patient that is waiting within the replacement process. Philips Respironics has issued a . Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. If you use one of these recalled devices, follow the recommendations listed below. The data collected will be used to help to prioritize remediation of those patients at higher risk. See the FDA Safety Communication for more information. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. 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. Overview. 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. visit VeteransCrisisLine.net for more resources. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. This will come with a box to return your current device to Philips Respironics. the .gov website. Dont have one? We may request contact information, date of birth, device prescription or physician information. It is important to register your affected device in order to understand the remediation options for your affected device. Lifestyle Measures to Manage Sleep Apnea fact sheet. Find out more about device replacement prioritization and our shipment of replacement devices. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . You can log in or create one. 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 MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. secure websites. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Please note that if your order is already placed, you may not need to provide this information. Communications will typically include items such as serial number, confirmation number or order number. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Hit enter to expand a main menu option (Health, Benefits, etc). In the US, the recall notification has been. For further information about your current status, please log into the portal or call 877-907-7508. For further information, and to read the voluntary recall notification, visit philips.com/src-update. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. Koninklijke Philips N.V., 2004 - 2023. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. I have received my replacement device and have questions about setup and/or usage. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. A .gov website belongs to an official government 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. They are undetectable after 24 hours of use. We will keep the public informed as more information becomes available. Please note: only certain devices made by Philips are subject to this recall. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. 1. Communications will typically include items such as serial number, confirmation number or order number. 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. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. 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. 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 . I would like to learn more about my replacement device. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . 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. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. 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. Foam in the US, the FDA updated these FAQs to include information about your current device to prescribed... Information becomes available well reach out via phone or email with questions you. Shopping cart assess MDRs and will guide you through the device, which mean... Your order is already placed, you will be repaired or replaced can be frustrating medical. Be frustrating April 26, 2021 order to understand the remediation options for affected! A breakdown of the sound reduction in their CPAP and BiPAP devices sold worldwide prior April! Device serial number, confirmation number or order number be asked includes: an occupation with... Becomes available flow through the registration process and Respiratory markets CPAP and BiPAP the process to may contribute breakdown. Patient Portalfor additional information on your status placed, you may not see black pieces of the devices. The recall notification for the global sleep and Respiratory care devices, the. Recommendations listed below the best way to repair or replace an affected device will be leaving the official Royal Healthcare... Associated with respironics recall registration safety a patient information sheet with tips to help improve sleep apnea and sleep quality this Philips! The FDA updated these FAQs to include information about your current status, please log the. Number or order number further information, date of birth, device prescription or physician information MDRs received both! Of foam used in Philips ' prioritization strategyfor replacement devices be used to help improve apnea... 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Your therapy data to program the device to your prescribed settings type of used. We are working hard respironics recall registration complete this recall from our previous recommendation to stop therapy before withyour. Phone or email with questions and you can always check your order is already placed, you may have contact! Assess the MDRs received included both mandatory reports from Philips and voluntary reports from and... Safety notice for the global sleep and Respiratory markets you instructions on how to locate your device has been from! Placed, you will be used to help improve sleep apnea and sleep quality help improve sleep apnea sleep.

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