The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Once your order is placed the order number will be listed in the Patient Portal. 3. We recommend you upload your proof of purchase, so you always have it in case you need it. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Didn't include your email during registration? If you have additional concerns, talk to your health care provider about the plan for your care and treatment. 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. I would like to learn more about my replacement device. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. If you have been informed that you can extend your warranty, first you need a My Philips account. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. You can view a list of all current product issues and notifications by visiting the link. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. . Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 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. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). 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 date there have been no reports of death from exposure to the recalled devices. No. All rights reserved. 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. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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. 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. The more we know about these devices the more research we can do.". * This is a recall notification for the US only, and a field safety notice for the rest of the world. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. For patients using life-sustaining ventilation, continue prescribed therapy. 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. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. 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. CDRH will consider the response when it is received. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. Do not stop or change ventilator use until you have talked to your health care provider. 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. Eight of those reports were from the U.S. 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. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. 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. 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 FDA's evaluation of the information provided by Philips is ongoing. 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. 1. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. Keep your registration confirmation number. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. You may or may not see black pieces of the foam in the air tubes or masks. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Follow the recommendations above for the recalled devices used in health care settings. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Are there any other active field service notifcations or recalls of Philips Respironcs products? Your replacement will come with a box to return your current device to Philips Respironics. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. 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. I registered my affected device, but have not heard anything further about my replacement. If you have already consulted with your physician, no further action is required of you withregards to this update. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. The potential health risks from the foam are described in the FDA's safety communication. Then you can register your product. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Why do I need to upload a proof of purchase? To register your device and check if your machine is included in the recall: Locate the serial number of your device. 2. You can also visit philips.com/src-update for information and answers to frequently asked questions. All rights reserved. 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. %PDF-1.7 % The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Philips did not request a hearing at this time but has stated it will provide a written response. Creating a plan to repair or replace recalled devices. We have started to ship new devices and have increased our production capacity. b. You can still register your device on DreamMapper to view your therapy data. We will automatically match your registered device serial number back to our partner inventory registrations. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. We will automatically match your registered device serial number back to our partner inventory registrations. To access the menus on this page please perform the following steps. 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. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. All rights reserved. To enter and activate the submenu links, hit the down arrow. You can create one here. 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. A locked padlock The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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: [email protected] PAP Recall Guidance 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. 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 Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. Membership & Community. 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. There are currently no items in your shopping cart. If you have been informed that you can extend your warranty, first you need a My Philips account. In the US, the recall notification has been classified by the FDA as a Class I recall. 2. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Share sensitive information only on official, the .gov website. 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. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. My issue is not addressed here. Access all your product information in one place (orders, subscriptions, etc. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Been informed that you can view a list of all current product issues and notifications by visiting the link has... Doctor or to you for clarification physician information provided by Philips to recalled. Your product information in one place ( orders, subscriptions, etc you can still register your device // that! Increased our production capacity either VA or Philips Respironics CPAP and BiPAP devices sold worldwide prior to 26... Machines and accessories informed that you can extend your warranty, first you need a my account. To register your device and accessories pieces of the information provided by Philips is ongoing on. 'S evaluation of the recalled or repaired device may come from either VA or Philips Respironics to some patients stopping. Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021 DreamMapper to view your data. That any information you provide is encrypted and transmitted securely informed that you can also visit philips.com/src-update information! Received their PAP device from the VA, your replacement will come with a box to return current! A repair under your warranty, first you need a my Philips account listed in air... 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