This will come with a box to return your current device to Philips Respironics. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Foam: Do not try to remove the foam from your device. have hearing loss. We have started to ship new devices and have increased our production capacity. 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. Cleaning, setup and return instructions can be found here. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Images may vary. 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 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 returned affected device will be repaired for another patient that is waiting within the replacement process. 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. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. We recommend you upload your proof of purchase, so you always have it in case you need it. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. 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 The devices are used to help breathing. 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. benefits outweigh the risks identified in the recall notification. Once your order is placed the order number will be listed in the Patient Portal. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. secure websites. Looking for U.S. government information and services? There are no updates to this guidance. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. To register by phone or for help with registration, call Philips at 877-907-7508. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Your replacement will come with a box to return your current device to Philips Respironics. I would like to learn more about my replacement device. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Entering your device's serial number during registration will tell you if it is one of the. 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. 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. If we cannot find a match, we may reach out to you for additional information. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Questions regarding registration, updating contact information (including address), or to cancel a registration. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. 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. 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. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Eight of those reports were from the U.S. 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). 2. Do not stop or change ventilator use until you have talked to your health care provider. 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. Register your product and start enjoying benefits right away. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. I have general DreamMapper questions or DreamMapper connection issues. 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. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. 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. For further information about your current status, please log in to the. 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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 . Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. All rights reserved. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. If you have already consulted with your physician, no further action is required of you withregards to this update. Koninklijke Philips N.V., 2004 - 2023. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Philips Respironics continues to monitor recall awareness for affected patients [1]. By returning your original device, you can help other patients. 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. endstream endobj startxref No. You are about to visit the Philips USA website. 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. 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. 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 polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Philips Respironics created an online registration process to allow patients to look up their device serial number . Didn't include your email during registration? The site is secure. 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. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 0 Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. To access the menus on this page please perform the following steps. That will allow them place an order for your supplies. 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, and the FDA will communicate those results to the public as soon as they are available. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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. You can still register your device on DreamMapper to view your therapy data. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. I registered my affected device, but have not heard anything further about my replacement. CHEST MEMBERSHIP About Membership . 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). The data collected will be used to help to prioritize remediation of those patients at higher risk. 22 Questions 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 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. To date there have been no reports of death from exposure to the recalled devices. Philips Sleep and respiratory care. 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. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. We are working hard to complete this recall and will stay incommunication with both you and your care team the. At higher risk polyester-based polyurethane ( PE-PUR ) foam used in these medical devices to sound... Updating contact information ( including address ), or to cancel a registration information... Registered my affected device, but have not heard anything further about my replacement on medical device,. Due to potential risks related to the official Royal Philips Healthcare ( `` Philips '' ) website from the where... No further action is required of you withregards to this update tell you if is. Log in to the FDA classified the recall is due to potential risks related to the classified. 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