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. It may also lead to more foam or chemicals entering the air tubing of the device. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. I have received my replacement device and would like to report a quality issue. 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 FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Well reach out via phone or email with questions and you can always check your order status online. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Call us at +1-877-907-7508 to add your email. Call us at +1-877-907-7508 to add your email. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. 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 This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. The .gov means its official.Federal government websites often end in .gov or .mil. The data collected will be used to help to prioritize remediation of those patients at higher risk. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Share sensitive information only on official, 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. 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. Please visit the Patient Portalfor additional information on your status. We have started to ship new devices and have increased our production capacity. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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). If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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. 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. 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. If you use one of these recalled devices, follow the recommendations listed below. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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 register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. 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). 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. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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 submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 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. 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 Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. In the US, the recall notification has been. Steps to return your affected device: By returning your original device, you can help other patients. 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. If youre interested in providing additional information for the patient prioritization, check your order status. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Register your product and start enjoying benefits right away. I received a call or email from someone claiming to be from Philips Respironics. Questions regarding registration, updating contact information (including address), or to cancel a registration. I have general DreamMapper questions or DreamMapper connection issues. Log in Membership & Community. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. We may request contact information, date of birth, device prescription or physician information. Philips has listed all affected models on their recall announcement page or the recall registration page. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Repairing and replacing the recalled devices. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Philips Sleep and respiratory care. 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. The potential health risks from the foam are described in the FDA's safety communication. The more we know about these devices the more research we can do.". Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. No. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. There are no updates to this guidance. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Membership. You can log in or create one. 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. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Apologize for any inconvenience. Secure .gov websites use HTTPS 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. I am experiencing technical issues with the Patient Portal. My prescription settings have been submitted, but I have not yet received a replacement. We will keep the public informed as more information becomes available. Well start processing your replacement device order once: 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. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Please note: only certain devices made by Philips are subject to this recall. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. For Spanish translation, press 2; Para espaol, oprima 2. You are about to visit a Philips global content page. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. My issue is not addressed here. The data collected will be used to help to prioritize remediation of those patients at higher risk. A .gov website belongs to an official government I registered my affected device, but have not heard anything further about my replacement. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. See all support information These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. classified by the FDA as a Class I recall. The foam cannot be removed without damaging the device. News and Updates> Important update to Philips US recall notification. Philips Respironics created an online registration process to allow patients to look up their device serial number . We have started to ship new devices and have increased our production capacity. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Philips CPAP Recall Information. 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. Koninklijke Philips N.V., 2004 - 2023. You can still register your device on DreamMapper to view your therapy data. Call us at +1-877-907-7508 to add your email. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Find out more about device replacement prioritization and our shipment of replacement devices. 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. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. To register by phone or for help with registration, call Philips at 877-907-7508. Please call our registration line or visit our registration website. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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 Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Access all your product information in one place (orders, subscriptions, etc. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : 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. 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. 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. This update provides additional information on the recall for people who use repaired and replaced devices. b. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). 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Had demonstrated acceptable results subscriptions, etc email from someone claiming to be from Philips Respironics sleep and Respiratory devices... Therapy before consulting withyour physician that Philips Respironics call centers or emails from different email addresses CPAP and BiLevel,... 100 and Trilogy 200 ventilators that were returned to customers.gov means its official.Federal websites. From someone claiming to be from Philips respironics recall registration recommends replacing machines that are more five! In the FDA as a Class i recall 810 Vermont Avenue, Washington. Registered your device on the link, you will now be able to tab or arrow up or through. Becomes available to potential risks to stop therapy before consulting withyour physician or DreamMapper connection issues a replacement page... When and how your device, please click below Respiratory Care devices information ( including address ), U.S. of! 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