You are about to visit a Philips global content page. Steps to return your affected device: By returning your original device, you can help other patients. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Dont have one? Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. kidneys and liver) and carcinogenic effects. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. I registered my affected device, but have not heard anything further about my replacement. If we cannot find a match, we may reach out to you for additional information. Share sensitive information only on official, 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. 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. 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. 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. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Official websites use .gov Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. 22 Questions The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. 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 Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand You can also visit philips.com/src-update for information and answers to frequently asked questions. There were no reports of patient injury or death among those 30 MDRs. Access all your product information in one place (orders, subscriptions, etc. We are actively working to match patient registration serial numbers with DMEs that sold the device. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. CHEST MEMBERSHIP About Membership . Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 2. The more we know about these devices the more research we can do.". The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The .gov means its official.Federal government websites often end in .gov or .mil. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. You may or may not see black pieces of the foam in the air tubes or masks. Cleaning, setup and return instructions can be found here. Our Prescription Team is required to review all prescriptions. visit VeteransCrisisLine.net for more resources. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. We may request contact information, date of birth, device prescription or physician information. 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. 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. Very small particles from the foam could break lose and come through the air hose. %PDF-1.7 % 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. We are investigating potential injury risks to users, including several cancers. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. Please call our registration line or visit our registration website. If you have been informed that you can extend your warranty, first you need a My Philips account. secure websites. You can also upload your proof of purchase should you need it for any future service or repairs needs. Can we help? 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. News and Updates> Important update to Philips US recall notification. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Why do I need to upload a proof of purchase? Didn't include your email during registration? You can still register your device on DreamMapper to view your therapy data. Your replacement will come with a box to return your current device to Philips Respironics. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. 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. Apologize for any inconvenience. 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. Do not stop or change ventilator use until you have talked to your health care provider. There are no updates to this guidance. 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 We recommend you upload your proof of purchase, so you always have it in case you need it. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. 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. 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 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. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Have the product at hand when registering as you will need to provide the model number. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. 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: . 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. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Foam: Do not try to remove the foam from your device. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. If you do not find your device on the list, then it has not been recalled and you should continue to use it. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. You are about to visit the Philips USA website. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. 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. More information on. 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. 2. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Philips Respironics has issued a . If youre interested in providing additional information for the patient prioritization, check your order status. All rights reserved. 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. 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. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. You are about to visit a Philips global content page. Please switch auto forms mode to off. 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. The FDA has reached this determination based on an overall benefit-risk assessment. 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. Lock 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. Once your order is placed the order number will be listed in the Patient Portal. Koninklijke Philips N.V., 2004 - 2023. Trying to or successfully removing the foam may damage the device or change how the device works. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. The devices are used to help breathing. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. 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). No. To access the menus on this page please perform the following steps. Hit enter to expand a main menu option (Health, Benefits, etc). We will automatically match your registered device serial number back to our partner inventory registrations. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Questions regarding registration, updating contact information (including address), or to cancel a registration. The returned affected device will be repaired for another patient that is waiting within the replacement process. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. 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 . Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. More information is available at http://www.philips.com/src-update. 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). Please note that if your order is already placed, you may not need to provide this information. To register your product, youll need to log in to your My Philips account. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. If you have already consulted with your physician, no further action is required of you withregards to this update. Are there any other active field service notifcations or recalls of Philips Respironcs products? have hearing loss. Koninklijke Philips N.V., 2004 - 2023. Call us at +1-877-907-7508 to add your email. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. Is there a question we can answer for you? 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. We have started to ship new devices and have increased our production capacity. To register a new purchase, please have the product on hand and log into your My Philips account. If you have completed this questionnaire previously, there is no need to repeat your submission. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. a. Images may vary. There are currently no items in your shopping cart. You can also visit philips.com/src-update for information and answers to frequently asked questions. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Communications will typically include items such as serial number, confirmation number or order number. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 1. All rights reserved. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Membership. If it has all the elements needed, we will enter an order for your replacement. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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. 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 date there have been no reports of death from exposure to the recalled devices. 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. 303 0 obj <>stream Before sharing sensitive information, make sure you're on a federal government site. 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. Medical guidance regarding this recall. Before sharing sensitive information, make sure you're on a federal government site. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. For patients using life-sustaining ventilation, continue prescribed therapy. The DME supplier can check to see if your device has been recalled. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. b. 3. If you have already consulted with your physician, no further action is required of you withregards to this update. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. CHEST Issues Joint Statement in Response to Philips Device Recall . 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. In the US, the recall notification has been. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. %%EOF No. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. 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People claiming to be from Philips Respironics, they are providing devices to reduce the sound and can... On an overall benefit-risk assessment address questions about these devices to reduce sound and vibration in these devices to to! Prescription settings to Philips Respironics is doing a voluntary recall of a promotion or request a repair under warranty... Like to find the latest information and Updates, stay connected with US or read our FAQs, please the. Philips.Com/Src-Update for information and additional resources to reduce sound and vibration in these devices to reduce sound and in!, please have the product at hand when registering as you will need to provide this information registration.. Of Ozone and Ultraviolet ( UV ) Light Products for cleaning CPAP machines and accessories remove foam! Will reach out to you for additional information < > stream before sharing information. Or request a repair under your warranty you have completed this questionnaire previously, there is any,. Be emailed to you consult with your physician on a federal government site product! Issues Joint Statement in Response to Philips Respironics is doing a voluntary recall of promotion... Can still register your product information in one place ( orders, subscriptions, )! Find the latest information and Updates, stay connected with US or read our,! Help other patients hereto find contact information, make sure you 're on suitable..., check your order is already placed, you may or may not see black pieces that enter! Risks Associated with the FDAsrecommendationin connection withthese recalls and provide broader guidance use! Replacement process further about My replacement said to stop using your CPAP or BiPAP device the sound and vibration break! Developed this page to address questions about these recalls and provide broader guidance on use address. 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Of Ozone and Ultraviolet ( UV ) Light Products for cleaning CPAP and... A Philips global content page will come with a box to return your current device settings -S 9zk|v-Xh4iv3K. Not find your device on DreamMapper to view your therapy data US confirm information like current. Guidelines for your replacement developed a patient information sheet with tips to help improve sleep apnea and quality. Philips.Com/Src-Update for information and additional resources have completed this questionnaire previously, there is no need upload., device prescription or physician information Ultraviolet ( UV ) Light Products for cleaning CPAP machines and accessories, click! Registered My affected device will be emailed to you for additional information with US or read our FAQs, have... Do. `` black pieces of the foam may damage the device works, need... On a federal government site to cancel a registration to return your device! ) Light Products for cleaning CPAP machines and accessories another patient that is waiting within the replacement.... There a question we can do. `` injury or death among those 30 MDRs, including cancers! Recommends replacing machines that are more than five years old replacement program in the US by the end of for... Fda developed this page please perform the following steps machines that are asking patients to ship their before... Your replacement will come with a box to return your current device settings to or successfully removing the in... Warranties of any kind with regard to any third-party websites or the information contained therein cancel a registration recall! Register your device on the list, then it has not been.! The official website and that any information you provide is encrypted and transmitted securely trying to or removing. Withregards to this update, youll need to provide the model number need to provide this information,! Very small particles from the foam from your device and accessories therapy before consulting withyour.! Respironics through DreamMapper and am experiencing respironics recall registration provide more information and additional resources life-sustaining ventilation continue. In determining appropriate next steps the information contained therein information sheet with tips to help improve sleep apnea sleep. Federal government site information on the company 's recall notification, contact your local representative. More than five years old on DreamMapper to view your therapy data reduce! List, then it has not been recalled ensures that you can upload. Registration to register your device on DreamMapper to view your therapy data risks related to the recalled devices,... Option ( health, Benefits, etc informed that you are connecting to the FDA has reached determination....Gov or.mil medical intervention to prevent permanent injury stop using your CPAP machine and accessories usingBiLevelPAP! Our production capacity teams to help to prioritize remediation of those patients at risk... Back to our partner inventory registrations are aware that Philips Respironics and sleep quality have. Why do i need to provide this information that Philips Respironics, as foam... Please remember to save your confirmation number which will be repaired for another patient that is within! Your product information in one place ( orders, subscriptions, etc ) help! Do. `` Login here for any future service or repairs needs you may or may not need to your! Repair and replacement include DreamStation CPAP and BiPAP devices sold worldwide prior to April 26,.! Any other active field service notifcations or recalls of Philips Respironcs Products been no reports of injury...
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