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. 272 0 obj <> endobj Log in You are about to visit a Philips global content page. 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. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Your replacement will come with a box to return your current device to Philips Respironics. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. For patients using life-sustaining ventilation, continue prescribed therapy. I have received my replacement device and would like to report a quality issue. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Lock During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). 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. Identifying the recalled medical devices and notifying affected customers. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. Are there any other active field service notifcations or recalls of Philips Respironcs products? Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. The relevant heath information that will be asked includes: An occupation associated with public safety. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. You are about to visit the Philips USA website. * This is a recall notification for the US only, and a field safety notice for the rest of the world. News and Updates> Important update to Philips US recall notification. %%EOF For patients using life-sustaining ventilation, continue prescribed therapy. Dont have one? This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. To register a new purchase, please have the product on hand and log into your My Philips account. Lifestyle Measures to Manage Sleep Apnea fact sheet. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. 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. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. The full report is available here. 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. Membership. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA's evaluation of the information provided by Philips is ongoing. Koninklijke Philips N.V., 2004 - 2023. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. See the FDA Safety Communication for more information. 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 . 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). Have the product at hand when registering as you will need to provide the model number. 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). To enter and activate the submenu links, hit the down arrow. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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. Please note that if your order is already placed, you may not need to provide this information. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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 polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 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. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Medical guidance regarding this recall. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. You can also visit philips.com/src-update for information and answers to frequently asked questions. visit VeteransCrisisLine.net for more resources. 22 Questions Images may vary. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. 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. You can create one here. In the US, the recall notification has been. Philips Sleep and respiratory care. 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 use one of these recalled devices, follow the recommendations listed below. If you have completed this questionnaire previously, there is no need to repeat your submission. The foam cannot be removed without damaging the device. An official website of the United States government. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. 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 If you have been informed that you can extend your warranty, first you need a My Philips account. To access the menus on this page please perform the following steps. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. 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. Is there a question we can answer for you? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We will automatically match your registered device serial number back to our partner inventory registrations. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. 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. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Koninklijke Philips N.V., 2004 - 2023. 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. The DME supplier can check to see if your device has been recalled. 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 is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). The FDA recognizes that many patients have questions about what this information means for the status of their devices. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. How can I tell if a recent call, letter or email is really from Philips Respironics? For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. If youre interested in providing additional information for the patient prioritization, check your order status. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The full report is available here. 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. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. You can log in or create one here. Call us at +1-877-907-7508 to add your email. 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. Apologize for any inconvenience. I would like to learn more about my replacement device. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. If you have been informed that you can extend your warranty, first you need a My Philips account. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . For further information, and to read the voluntary recall notification, visit philips.com/src-update. For further information, and to read the voluntary recall notification, visit philips.com/src-update. The returned affected device will be repaired for another patient that is waiting within the replacement process. We are actively working to match patient registration serial numbers with DMEs that sold the device. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. I registered my affected device, but have not heard anything further about my replacement. 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. If you have already consulted with your physician, no further action is required of you withregards to this update. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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). Before sharing sensitive information, make sure you're on a federal government site. Keep your registration confirmation number. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. For Spanish translation, press 2; Para espaol, oprima 2. The full report is available here. 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. 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. 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 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 . Register your product and start enjoying benefits right away. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. You are about to visit a Philips global content page. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. benefits outweigh the risks identified in the recall notification. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. If you do not find your device on the list, then it has not been recalled and you should continue to use it. the .gov website. 2. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. That will allow them place an order for your supplies. More information is available at http://www.philips.com/src-update. Please note: only certain devices made by Philips are subject to this recall. Cleaning, setup and return instructions can be found here. 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. 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. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Consult with your physician as soon as possible to determineappropriate next steps. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. 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