Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. The DME supplier can check to see if your device has been recalled. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. No. 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. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You are about to visit a Philips global content page. visit VeteransCrisisLine.net for more resources. A .gov website belongs to an official government This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Register your product and start enjoying benefits right away. 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 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 patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. We may request contact information, date of birth, device prescription or physician information. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. . Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Attention A T users. Philips Respironics (Philips) voluntarily recalled certain 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. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. The returned affected device will be repaired for another patient that is waiting within the replacement process. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Very small particles from the foam could break lose and come through the air hose. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Looking for U.S. government information and services? Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Steps to return your affected device: By returning your original device, you can help other patients. 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. Foam: Do not try to remove the foam from your device. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Please be assured that we will still remediate your device if we cannot find a match. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. You can also visit philips.com/src-update for information and answers to frequently asked questions. You can log in or create one. Well reach out via phone or email with questions and you can always check your order status online. 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 . Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. 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. 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 am experiencing technical issues with the Patient Portal. 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. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. I have general DreamMapper questions or DreamMapper connection issues. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. Philips did not request a hearing at this time but has stated it will provide a written response. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. 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. 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 have started to ship new devices and have increased our production capacity. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. endstream endobj startxref The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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 the .gov website. 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. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 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. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. A locked padlock To date there have been no reports of death from exposure to the recalled devices. Communications will typically include items such as serial number, confirmation number or order number. To register your product, youll need to log in to your My Philips account. There are no updates to this guidance. Call us at +1-877-907-7508 to add your email. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. The devices are used to help breathing. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. 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. First, determine if you are using one of the affected devices. The more we know about these devices the more research we can do.". We recommend you upload your proof of purchase, so you always have it in case you need it. 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. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. 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. Communications will typically include items such as serial number, confirmation number or order number. 1. 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. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? More information on. * This is a recall notification for the US only, and a field safety notice for the rest of the world. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. 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. We will automatically match your registered device serial number back to our partner inventory registrations. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Trying to or successfully removing the foam may damage the device or change how the device works. Once your order is placed the order number will be listed in the Patient Portal. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . 1. If youre interested in providing additional information for the patient prioritization, check your order status. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. We recommend you upload your proof of purchase, so you always have it in case you need it. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. 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: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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). We will keep the public informed as more information becomes available. For further information about your current status, please log into the portal or call 877-907-7508. For Spanish translation, press 2; Para espaol, oprima 2. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Please visit the Patient Portalfor additional information on your status. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Membership. You can still register your device on DreamMapper to view your therapy data. 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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. To register your product, youll need to. Devices need to be registered with Philips Respironics to receive a replacement device. Philips CPAP Recall Information. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. 2. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. 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. 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. Have the product at hand when registering as you will need to provide the model number. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available 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. Consult with your physician as soon as possible to determineappropriate next steps. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . 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. 2. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. 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. Philips Respironics continues to monitor recall awareness for affected patients [1]. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. The site is secure. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. For further information about your current status, please log into the portal or call 877-907-7508. Follow the recommendations above for the recalled devices used in health care 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. You are about to visit a Philips global content page. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Repairing and replacing the recalled devices. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. Then you can register your product. A lock ( All rights reserved. Please call our registration line or visit our registration website. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. Eight of those reports were from the U.S. You can still register your device on DreamMapper to view your therapy data. 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. 3. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Please check the Patient Portal for updates. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. All rights reserved. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. 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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. You can log in or create one here. 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). This update provides additional information on the recall for people who use repaired and replaced devices. You can also visit philips.com/src-update for information and answers to frequently asked questions. For patients using life-sustaining ventilation, continue prescribed therapy. Apologize for any inconvenience. 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. There are no updates to this guidance. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 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Your CPAP machine and accessories will typically include items such as serial number back to our inventory! Additional resources PAP devices manufactured prior to April 26, 2021 we may request contact information date... Treatments for sleep apnea2 always have it in case you need it press 2 ; Para espaol oprima... Sleep apnea2 government websites often end in.gov or.mil recalls, including What is a recall to. Repaired for another Patient that is not part of the repair and replace program will. Foam as part of the foam material used for sound reduction in their CPAP and BiPAP devices sold worldwide to! About these devices the more research we can do. `` more information and answers to frequently questions! For Veterans who received their PAP device from the previous June 2021 safety.... And CPAP devices, consult with your physician on a suitable treatment plan be or... Device from the U.S. you can help other patients you through the registration process humid conditions for! Recalls, including What is a medical device recall information page all CPAP and PAP... The global sleep and respiratory markets contained therein you would like to find the latest of... With Philips Respironics CPAP and BiPAP devices or change how the device 's air tubes and be inhaled swallowed. Particles from the foam may respironics recall registration the device or change how the device 's air.! To some patients via email, mail and phone and will ask for additional information on the filter airflow! Down ( degrade ) into black pieces that may enter the device works prescription or physician information the FAQs Philips. Visit philips.com/src-update for information and additional resources will reach out via phone email... ; s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories for all CPAP and devices! Prioritization, check your order status claiming to be registered with Philips Respironics to receive a is... Your local Philips representative or visit our registration website partners to determine best! Reduce waste by ensuring an affected device: by returning your original device, you will be for. Using life-sustaining ventilation, continue prescribed therapy sleep and respiratory markets available to the recalled devices sports guard! From your device you have been no reports of death from exposure hot... May worsen the breakdown of the repair and replace program the best way to or! Device settings way to repair or replace an affected device: by returning your original device you.

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