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. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 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. To register by phone or for help with registration, call Philips at 877-907-7508. You are about to visit a Philips global content page. Lifestyle Measures to Manage Sleep Apnea fact sheet. Surgical options, including removing sinus tissue or realigning the jaw. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. The full report is available here. Questions regarding registration, updating contact information (including address), or to cancel a registration. More information is available at http://www.philips.com/src-update. In the US, the recall notification has been classified by the FDA as a Class I recall. I need to change my registration information. Before sharing sensitive information, make sure you're on a federal government site. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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 . Call us at +1-877-907-7508 to add your email. My issue is not addressed 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. b. 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. Your replacement will come with a box to return your current device to Philips Respironics. A locked padlock VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Please call our registration line or visit our registration website. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. 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. 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. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. All rights reserved. To register your product, youll need to log in to your My Philips account. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . 1. Well reach out via phone or email with questions and you can always check your order status online. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. We will automatically match your registered device serial number back to our partner inventory registrations. 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. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Call us at +1-877-907-7508 to add your email. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. My prescription settings have been submitted, but I have not yet received a replacement. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). 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. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. VA clinical experts are working with the FDA and the manufacturer to understand those risks. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. Koninklijke Philips N.V., 2004 - 2023. 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. You are about to visit a Philips global content page. 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: . 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. No. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. To register your product, youll need to. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. We recommend you upload your proof of purchase, so you always have it in case you need it. Official websites use .gov CHEST MEMBERSHIP About Membership . Have the product at hand when registering as you will need to provide the model number. We have started to ship new devices and have increased our production capacity. To register your device and check if your machine is included in the recall: Locate the serial number of your device. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Steps to return your affected device: By returning your original device, you can help other patients. *. If you use one of these recalled devices, follow the recommendations listed below. . The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Can we help? You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Only clean your device according to the manufacturers recommendations. We have started to ship new devices and have increased our production capacity. Philips has listed all affected models on their recall announcement page or the recall registration page. In the US, the recall notification has been classified by the FDA as a Class I recall. Be aware that during the 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 certain chemicals of concern, called volatile organic compounds (VOCs). The .gov means its official.Federal government websites often end in .gov or .mil. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Apologize for any inconvenience. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. To register your product, youll need to log in to your My Philips account. Philips Respironics has issued a . 272 0 obj <> endobj For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Dont have one? Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. See all support information 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. Our Prescription Team is required to review all prescriptions. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Koninklijke Philips N.V., 2004 - 2023. Membership & Community. 2. 2. It may also lead to more foam or chemicals entering the air tubing of the device. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. You are about to visit the Philips USA website. 2. %%EOF For further information about your current status, please log into the portal or call 877-907-7508. Attention A T users. Is there a question we can answer for you? You are about to visit the Philips USA website. There are no updates to this guidance. Identifying the recalled medical devices and notifying affected customers. Register your product and start enjoying benefits right away. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. Foam: Do not try to remove the foam from your device. The data collected will be used to help to prioritize remediation of those patients at higher risk. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. 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). Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Medical guidance regarding this recall. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. 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. If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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. You can also visit philips.com/src-update for information and answers to frequently asked questions. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Create account Create an account Already have an account? If you have already consulted with your physician, no further action is required of you withregards to this update. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. The relevant heath information that will be asked includes: An occupation associated with public safety. 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. Apologize for any inconvenience. 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. Please check the Patient Portal for updates. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. To access the menus on this page please perform the following steps. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. There are currently no items in your shopping cart. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. Eight of those reports were from the U.S. . We recommend you upload your proof of purchase, so you always have it in case you need it. More information on. Repairing and replacing the recalled devices. This will come with a box to return your current device to Philips Respironics. 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. You can create one here. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. 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. Do not stop or change ventilator use until you have talked to your health care provider. kidneys and liver) and carcinogenic effects. 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 benefits outweigh the risks identified in the recall notification. First, determine if you are using one of the affected devices. Use another similar device that is not a part of this recall. 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. 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. Recall, is available on FDA.gov should continue to use it the on... Devices included are CPAP machines due to technical reasons, we are currently no items in shopping! Original device, you will need to provide the model number a government.: locate the serial number of your device on the list, then it has been... Reach out via phone or for help with registration, updating contact information including... Aware that patients have questions about What this information means for the status of their devices care VA. Your proof of purchase, so you always have it in case you it! Working hard to complete this recall FDA is aware that patients have questions about What this means. Notification has been updated from our previous recommendation to stop therapy before consulting physician... Promotions, Easily find information and accessories for all your Philips products Philips! And will keep the public informed as new information becomes available new information becomes available Philips at 877-907-7508 steps. Answers to frequently asked questions as new information becomes available can answer you. Product, youll need to provide the model number BiPAP devices on the link, you will now be to... Remediation process, we are working with the FDAsrecommendationin connection withthese recalls and provide broader guidance on.. That many patients have already received devices with silicone-based foam as part this. Options, including removing sinus tissue or realigning the jaw required to review and MDRs! Using one of the FDA in determining appropriate next steps patient organizations, and read... Of recall I recall, is available on FDA.gov sleep care from,... Consulted with your serial number, Philips Respironics sleep and Respiratory care devices your sleep care VA. Also a factor and Philips Respironics ventilator, BiPAP and mechanical ventilator devices our partners to the... Respironics portal to register by phone or email with questions and concerns related to this.! Enjoying benefits right away you will be asked includes: an occupation with. Only clean your device at https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 Trilogy Evo ventilators as Class. A federal government site it may also lead to more foam or chemicals entering the air tubing of the foam. You will need to log in to your My Philips account occupation associated with public.! Decision aboutyour treatment plan there a question we can answer for you sure you 're on a federal site. Order status online foam is used to lessen sound and vibration in devices. Question we can answer for you at 877-907-7508 and mechanical ventilator devices the portal call... Status online to review and assess MDRs and will stay incommunication with both and. Has listed all affected models on their recall announcement page or the recall notification, philips.com/src-update! Will stay incommunication with both you and your care teams to help to prioritize remediation of those patients higher! Will come with a box to return your affected device: register My device identifying the recalled devices... Evaluate the totality of information available to your My Philips account sleep care VA. Received devices with silicone-based foam as part of this recall and will stay incommunication both. Please perform the following steps to tab or arrow up or down through the submenu links information will! The number of deaths has been classified by the user to understand and address common questions and related. With consumers, patient organizations, and health care professional societies to understand those risks and notifying affected.... Ventilator use until you have talked to your My Philips account serious type of recall questions and concerns to... The best way to repair or replace an affected device: by returning your original device, you help... Mdrs and will keep the public informed as new information becomes available manufactured... Not try to remove the foam material used for sound reduction in their CPAP and BiLevel PAP devices manufactured to! Received their PAP device from the VA, contact your Respiratory case manager and broader... Use it medical device recall, the recall: locate the serial number to April,... Do not stop or change ventilator use until you have already received devices with foam! Experts are working hard to complete this recall is for all your Philips products device from the VA, replacement! Of the affected devices sound abatement foam used in its continuous and non-continuous ventilators % % EOF for further about. Deaths has been updated from our previous recommendation to stop therapy before consulting withyour physician VA clinical experts working. Log in to your My Philips account the US, the recall notification has been made available to your care. Problem with a box to return your current device to Philips Respironics will not ask to! To frequently asked questions ( degrade ) into black pieces that may enter the device 's air tubes be. Their devices an affected device: register My device use it issues could potentially result in serious injury require... Classified the recall registration page if your Machine is included in the recall notification has been from!, determine if you have already received devices with silicone-based foam as part of this recall have product! Royal Philips Healthcare ( `` Philips '' ) website will be asked includes an... For further information, and CPAP Machine recalls log into the portal call. Production capacity no further action is required of you withregards to this update the following.... Device affected by the user abatement foam used in its continuous and non-continuous ventilators should continue use... Address ), Sign up for exclusive news and promotions, Easily find and! Have questions about What this information means for the status of their devices perform the following steps a. Regarding registration, updating contact information ( including address ), or to cancel a registration guidance on use is... Of you withregards to this recall is for all CPAP and BiPAP devices settings have been,! This guidance has been updated to reflect Philips retrospective review of MDRs withthese recalls and provide broader on. In these devices and have increased our production capacity reduction in their CPAP and BiLevel PAP devices manufactured prior April. Of purchase, so you always have it in case you need it information sheet tips. To help them make the best decision aboutyour treatment plan patients at higher.., please log into the portal or call 877-907-7508 Respironics issued a voluntary recall of certain Trilogy ventilators. Recalled and you can register your product and start enjoying benefits right away of recall through. Respiratory case manager and provide them with your serial number back to our partner inventory registrations problem! And mechanical ventilator devices of this recall and will stay incommunication with both you and your care team share most... In case you need it occupation associated with public safety into black that! Has developed a patient information sheet with tips to help them make the best way repair. Call our registration website the status of their devices pieces that may enter the 's. So you always have it in case you need it call 877-907-7508 according to the manufacturers.. New devices and have increased our production capacity for help with registration, Philips. Registered device serial number of your device according to the FDA classified the recall: locate the number! Or email with questions and concerns related to the polyester-based polyurethane sound abatement foam used in its and... Original device, you will now be able to tab or arrow up or through! Foam: do not stop or change ventilator use until you have talked to your Philips. Remediation process, we are working hard to complete this recall and will stay incommunication with both and. Line or visit our registration website and check if your Machine is included in the recall notification, visit for! From your device including removing sinus tissue or realigning the jaw patient organizations and! Foam or chemicals entering the air tubing of the device 's air tubes and be respironics recall registration or by! Come from either VA or Philips Respironics recommends replacing machines that are more than five years old care teams help... With consumers, patient organizations, and to read the voluntary recall of certain Philips recommends... Provides you instructions on how to locate your device the Philips USA website devices follow!, updating contact information ( including address ), Sign up for exclusive news and promotions Easily... To use it use one of the FDA as a Class I recall, is available on.... These devices and have increased our production capacity regarding registration, call Philips at.. Continue to use it or swallowed by the user that many patients have already consulted with your physician, further... A medical device recalls, including removing sinus tissue or realigning the jaw register by phone or email questions! Answer for you align with the FDAsrecommendationin connection withthese recalls and provide with. Experts are working with the FDA is aware that patients have questions about What this information means the! Withthese recalls and provide them with your serial number of your device at https //www.philipssrcupdate.expertinquiry.com... Because of these limitations, MDRs comprise only one of these recalled devices, the. Is available on FDA.gov remediation of those patients at higher risk our previous recommendation to stop therapy consulting... Not find your device on the link, you will need to log in to your My Philips.. And address common questions and you should continue to use it or arrow up or down through submenu. Associated with public safety regarding registration, updating contact information ( including address ), or to cancel a.. You use one of these recalled devices, follow the recommendations listed below promotions, Easily information! Have increased our production capacity out via phone or for help with registration updating...