Philips did not request a hearing at this time but has stated it will provide a written response. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. The full report is available here. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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 register your product, youll need to log in to your My Philips account. 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 website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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. Have the product at hand when registering as you will need to provide the model number. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. You are about to visit a Philips global content page. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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). Philips Respironics created an online registration process to allow patients to look up their device serial number . c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. You can log in or create one here. 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. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. 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. 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. 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. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Overview. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. All rights reserved. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. kidneys and liver) and carcinogenic effects. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. 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? 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. You can create one here. Cleaning, setup and return instructions can be found here. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Very small particles from the foam could break lose and come through the air hose. Consult with your physician as soon as possible to determineappropriate next steps. No. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Apologize for any inconvenience. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Philips Respironics Sleep and Respiratory Care devices, 2. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Our Prescription Team is required to review all prescriptions. 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Communications will typically include items such as serial number, confirmation number or order number. Three types of devices have been recalled: 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 Trilogy 100 and Trilogy 200 ventilators. All rights reserved. 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. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. The FDA's evaluation of the information provided by Philips is ongoing. Use another similar device that is not a part of this recall. Looking for U.S. government information and services? Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Well reach out via phone or email with questions and you can always check your order status online. Well reach out via phone or email with questions and you can always check your order status online. Please note: only certain devices made by Philips are subject to this recall. News and Updates> Important update to Philips US recall notification. CHEST MEMBERSHIP About Membership . Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. A lock ( You can still register your device on DreamMapper to view your therapy data. How can I tell if a recent call, letter or email is really from Philips Respironics? Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. In the US, the recall notification has been. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. 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 would like to learn more about my replacement device. You can also visit philips.com/src-update for information and answers to frequently asked questions. Call us at +1-877-907-7508 to add your email. 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. If you have been informed that you can extend your warranty, first you need a My Philips account. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. During respironics recall registration, you can always check your order status online the us, the recall or Using alternative for. 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