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 . Find out more about device replacement prioritization and our shipment of 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. 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: only certain devices made by Philips are subject to this recall. For further information about your current status, please log into the portal or call 877-907-7508. The foam cannot be removed without damaging the device. a. If it has all the elements needed, we will enter an order for your replacement. All rights reserved. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Do not stop or change ventilator use until you have talked to your health care provider. Consult with your physician as soon as possible to determineappropriate next steps. 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. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. 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. If you use one of these recalled devices, follow the recommendations listed below. Dont have one? Access all your product information in one place (orders, subscriptions, etc. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. 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. How can I register my product for an extended warranty? 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. 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. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. We may request contact information, date of birth, device prescription or physician information. We recommend you upload your proof of purchase, so you always have it in case you need it. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. . b. 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 recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. *. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers 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. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 1. The FDA recognizes that many patients have questions about what this information means for the status of their devices. In this video, we will be going into detail about the process to register your device on the Philips website. You can also upload your proof of purchase should you need it for any future service or repairs needs. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. Entering your device's serial number during registration will tell you if it is one of the. 2. 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. Be cautious as they may be scams! You must register your recalled device to get a new replacement device. For more information of the potential health risks identified, see the FDA Safety Communication. Is there a question we can answer for you? Use another similar device that is not a part of this recall. CHEST Issues Joint Statement in Response to Philips Device Recall . 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 At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. A .gov website belongs to an official government %PDF-1.7 % For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. 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. 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. ) or https:// means youve safely connected to Well reach out via phone or email with questions and you can always check your order status online. Follow the recommendations above for the recalled devices used in health care settings. . Then you can register your product. 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. You can still register your device on DreamMapper to view your therapy data. Please call our registration line or visit our registration website. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Looking for U.S. government information and services? We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? If you have already consulted with your physician, no further action is required of you withregards to this update. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. To register your product, youll need to log in to your My Philips account. 2. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. 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. 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). The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. 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 . The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. The .gov means its official.Federal government websites often end in .gov or .mil. Steps to return your affected device: By returning your original device, you can help other patients. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Share sensitive information only on official, 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. The more we know about these devices the more research we can do.". 3. 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. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Images may vary. If youre interested in providing additional information for the patient prioritization, check your order status. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. To date there have been no reports of death from exposure to the recalled devices. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. To register a new purchase, please have the product on hand and log into your My Philips account. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. Have the product at hand when registering as you will need to provide the model number. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. You are about to visit a Philips global content page. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. 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. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. To access the menus on this page please perform the following steps. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ 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. the .gov website. 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. There are no updates to this guidance. All rights reserved. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. You are about to visit the Philips USA website. Call us at +1-877-907-7508 to add your email. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + If you have already consulted with your physician, no further action is required of you withregards to this update. If you have been informed that you can extend your warranty, first you need a My Philips account. Koninklijke Philips N.V., 2004 - 2023. No. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Not yet registered? 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. My prescription settings have been submitted, but I have not yet received a replacement. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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. classified by the FDA as a Class I recall. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. To register your product, youll need to log in to your My Philips account. It may also lead to more foam or chemicals entering the air tubing of the device. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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. Medical guidance regarding this recall. Lock We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. The site is secure. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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? Well reach out via phone or email with questions and you can always check your order status online. There are currently no items in your shopping cart. 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. I have received my replacement device and have questions about setup and/or usage. If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. 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