Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. You can log in or create one here. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Dont have one? * This is a recall notification for the US only, and a field safety notice for the rest of the world. %%EOF As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. The foam cannot be removed without damaging the 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Philips Respironics has issued a . A lock ( You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. By returning your original device, you can help other patients. You may have to contact your care provider to program the device to your prescribed settings. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. It may also lead to more foam or chemicals entering the air tubing of the device. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. No. 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. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. You are about to visit a Philips global content page. Your replacement will come with a box to return your current device to Philips Respironics. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. All rights reserved. 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. The site is secure. To register a new purchase, please have the product on hand and log into your My Philips account. To register your product, youll need to. You can also visit philips.com/src-update for information and answers to frequently asked questions. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You are about to visit a Philips global content page. Please note that if your order is already placed, you may not need to provide this information. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Call us at +1-877-907-7508 to add your email. Please check the Patient Portal for updates. secure websites. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. Consult with your physician as soon as possible to determineappropriate next steps. You can create one here. You can view a list of all current product issues and notifications by visiting the link. I would like to learn more about my replacement device. 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. 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: . endstream endobj startxref If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. 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. 2. If you use one of these recalled devices, follow the recommendations listed below. 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). Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Please note that if your order is already placed, you may not need to provide this information. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. benefits outweigh the risks identified in the recall notification. Call us at +1-877-907-7508 to add your email. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. You can create one here. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Medical guidance regarding this recall. 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. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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. Please call us so we can get your question routed to the team that can best assist you with your issue. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 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. Lifestyle Measures to Manage Sleep Apnea fact sheet. Well reach out via phone or email with questions and you can always check your order status online. 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. 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. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Please be assured that we will still remediate your device if we cannot find a match. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. There are currently no items in your shopping cart. Selected products Our Prescription Team is required to review all prescriptions. More information on. Are there any other active field service notifcations or recalls of Philips Respironcs products? For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Secure .gov websites use HTTPS Philips Respironics continues to monitor recall awareness for affected patients [1]. There were no reports of patient injury or death among those 30 MDRs. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Create account Create an account Already have an account? Koninklijke Philips N.V., 2004 - 2023. 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Eight of those reports were from the U.S. %PDF-1.7 % Philips has listed all affected models on their recall announcement page or the recall registration page. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Register your product and start enjoying benefits right away. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. In the US, the recall notification has been classified by the FDA as a Class I recall. 3. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. 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. The full report is available here. 0 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. 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. 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 . 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 makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Be cautious as they may be scams! For patients using life-sustaining ventilation, continue prescribed therapy. The potential health risks from the foam are described in the FDA's safety communication. 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. Learn more at www.vcf.gov . See all support information 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. A .gov website belongs to an official government 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. The devices are used to help breathing. 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. Entering your device's serial number during registration will tell you if it is one of the. I am experiencing technical issues with the Patient Portal. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. 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. 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