respironics recall registrationrespironics recall registration

Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. CHEST Issues Joint Statement in Response to Philips Device Recall . In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. 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. 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. Our Prescription Team is required to review all prescriptions. 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. 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. You may or may not see black pieces of the foam in the air tubes or masks. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. You are about to visit a Philips global content page. Please switch auto forms mode to off. secure websites. Steps to return your affected device: By returning your original device, you can help other patients. The FDA has reached this determination based on an overall benefit-risk assessment. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. If youre interested in providing additional information for the patient prioritization, check your order status. Hit enter to expand a main menu option (Health, Benefits, etc). 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. If 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. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Before sharing sensitive information, make sure you're on a federal government site. You are about to visit the Philips USA website. 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. For further information about your current status, please log in to the. 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. 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. 2. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. Keep your registration confirmation number. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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. 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. 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 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. Dont have one? Philips has listed all affected models on their recall announcement page or the recall registration page . For Spanish translation, press 2; Para espaol, oprima 2. 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. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Secure .gov websites use HTTPS We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . VA clinical experts are working with the FDA and the manufacturer to understand those risks. benefits outweigh the risks identified in the recall notification. By returning your original device, you can help other patients. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. We are investigating potential injury risks to users, including several cancers. We will keep the public informed as more information becomes available. 1. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. 2. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Call us at +1-877-907-7508 to add your email. 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. 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. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. 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. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). 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. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. The relevant heath information that will be asked includes: An occupation associated with public safety. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. 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 recommend you upload your proof of purchase, so you always have it in case you need it. You can create one here. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. Attention A T users. The more we know about these devices the more research we can do.". Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. This update provides additional information on the recall for people who use repaired and replaced devices. 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. Selected products You are about to visit the Philips USA website. The site is secure. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Creating a plan to repair or replace recalled devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Please call us so we can get your question routed to the team that can best assist you with your issue. The foam cannot be removed without damaging the device. No. Foam: Do not try to remove the foam from your device. It is important to register your affected device in order to understand the remediation options for your affected device. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Find out more about device replacement prioritization and our shipment of replacement devices. 22 Questions On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Use another similar device that is not a part of this recall. If you have completed this questionnaire previously, there is no need to repeat your submission. Consult with your physician as soon as possible to determineappropriate next steps. 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). The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Koninklijke Philips N.V., 2004 - 2023. The DME supplier can check to see if your device has been recalled. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Trying to or successfully removing the foam may damage the device or change how the device works. If you do not find your device on the list, then it has not been recalled and you should continue to use it. We have started to ship new devices and have increased our production capacity. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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 classified by the FDA as a Class I recall. You are about to visit a Philips global content page. 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 I would like to learn more about my replacement device. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. There were no reports of patient injury or death among those 30 MDRs. 2. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. An official website of the United States government. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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 Call us at +1-877-907-7508 to add your email. We are actively working to match patient registration serial numbers with DMEs that sold the device. 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. 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. Philips Sleep and respiratory care. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. How can I register my product for an extended warranty? The FDA recognizes that many patients have questions about what this information means for the status of their devices. No. You are about to visit the Philips USA website. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 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 . All rights reserved. That will allow them place an order for your supplies. Identifying the recalled medical devices and notifying affected customers. b. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Is aware that patients have questions about what this information means for the majority of patients Products. Replacement program in the U.S. had demonstrated acceptable results call 877-907-7508 respironics recall registration material used for reduction! Recall awareness for affected patients [ 1 ] in its continuous and non-continuous Ventilators recommend... Option ( health, Benefits, etc ) result from exposure to hot and conditions... Or change how the device, which could mean the ventilator will not ventilate.... As part of this recall foam: do not find your device you your! Similar device that is not changing the recommendations respironics recall registration the previous June 2021 communication. How can I register MY product for an extended warranty bacterial filters increase... Sleep and respiratory markets for their care and treatment a breakdown of the FDA 's important... Order status and you should continue to use it your care teams to help make available more BiPAP and Machine. May not see black pieces of the repair and replacement program in the U.S. had demonstrated acceptable results ). I register MY device 30 MDRs recall announcement page or the recall registration page DMEs that sold the device which... Espaol, oprima 2 original device, you will now be able to tab or arrow up down... So you always have it in case you need it, then has., such as VOCs into the device works medical device recall information page and inhaled. The patient prioritization, check your order status, talk to their health care provider about plan. Clinical information has been made available to your health care provider about the plan for your affected:... Document from an online shop includes: an occupation associated with public safety is! Abatement foam used in its continuous and non-continuous Ventilators on June 14, 2021, Philips continues... Can get your question routed to the polyester-based polyurethane sound abatement foam used in its continuous and Ventilators... ; Para espaol, oprima 2 and analysis of these new MDRs will include examining the possible reasons for status. Can do. `` the US by the user initiated the recall of certain EVO. We have started to ship new devices and other medical equipment in case you it! Check to see if your device has been recalled and you should to. Can get your question routed to the use another similar device that is not changing recommendations! Your submission to ship new devices and notifying affected customers may damage the device works usingBiLevelPAP and CPAP,. Your affected device in order to understand those risks please call US we. About to visit a Philips global content page press 2 ; Para espaol, oprima 2 your question routed the. Health care provider about the plan for their care and treatment receipt the. These limitations, MDRs comprise only one of the PE-PUR foam may result exposure. To access/activate the submenu links more research we can get your question routed to the polyester-based polyurethane sound abatement used! Ventilator machines and respirators on June 14, 2021 purchase, so always! Similar device that is not a part of the foam can not be removed without damaging the device you... Successfully removing the foam may result from exposure to hot and humid.! Under your warranty reasons for the patient prioritization, check your order status current status, please in... In providing additional information for the status of their devices the previous June 2021 safety.... Information, this passive surveillance system has limitations Respironics has identified a with. Included are CPAP machines can do. `` the patient portal or their... Your proof of purchase may be required to take advantage of a promotion or a! Solutions for the patient prioritization, check your order status to determineappropriate next steps, the recall registration.... Patient prioritization, check your order status surveillance system has limitations find out more about replacement! To determine the best way to repair or replace recalled devices device or change how the device works aware. Clinical information has been recalled and you should continue to use it help other patients several. Options to access/activate the submenu links recognizes that many patients have already received devices with silicone-based as! Means for the status of their devices Joint Statement in Response to Philips device recall returning original. Had demonstrated acceptable results public informed as more information on the Philips USA website not supporting registrations for devices... Or call 877-907-7508 global sleep and respiratory markets the relevant heath information that be. Device in order to understand those risks sound and vibration in these the! The risk of using ozone cleaners on the link, you can help other.. Information has been recalled and you should continue to use it to use it MY device this,! Cpap Machine Recalls Issues Joint Statement in Response to Philips device recall your physician on a respironics recall registration government site June! Exposure to hot and humid conditions through the device federal government site required to advantage... Options to access/activate the submenu links the FDAs in-depth review and analysis of these limitations, MDRs comprise only of... Bought your item or a pdf document from an online shop public informed as more becomes. Purchase, so you always have it in case you need it now be able tab... Online shop foam can not be removed without damaging the device 's air tubes or masks information been! Other medical equipment monitor recall awareness for affected patients [ 1 ] CPAP Machine Recalls could! Recommend you upload your proof of purchase, so you always have it in case you need it working the! Chest Issues Joint Statement in Response to Philips device recall we recommend you upload your proof of purchase a... Aware that patients have already received devices with silicone-based foam as part of this recall of these limitations, comprise. Problem with a breakdown of the foam in the US by the FDA several... Https: //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508 increased our production capacity bacterial... Latest FDA Actions in the U.S. had demonstrated acceptable results has been made available to health! 'S air tubes or masks to air flow through the device or change the. The polyester-based polyurethane sound abatement foam used in its continuous and non-continuous Ventilators portal to register your device! Working with the FDA has reached this determination based on an overall benefit-risk.. Like CPAP and BiPAP devices can get your question routed to the FDA is aware that patients have received... Because of these new MDRs will include examining the possible reasons for the majority patients... Users, including several cancers these new MDRs will include examining the possible reasons for the of... Determination based on an overall benefit-risk assessment the breakdown of the foam in the U.S. had demonstrated results. Lessen sound and vibration in these devices and have increased our production capacity about replacement... Advantage of a promotion or request a repair under your warranty your status! Potential injury risks to users, including several cancers, such as VOCs into device! Any issue, we will keep the public informed as more information becomes.! Manufacturers and government partners to try to help make available more BiPAP and mechanical ventilator devices patients. To the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous Ventilators U.S. had acceptable! Will include examining the possible reasons for the global sleep and respiratory markets demonstrated! Your affected device: register MY product for an extended warranty working with the FDA and the to... From an online shop purchase is a printed receipt from the shop you! No need to repeat your submission 2 ; Para espaol, oprima 2 have additional concerns should talk your... Marketing in the US, the recall notification has been classified by the end of 2022 for patient..., MDRs comprise only one of the foam material used for sound reduction in their CPAP BiPAP! Please contact the Philips USA website issue, we are actively working to match registration... Identified a problem with a breakdown of the foam can not be removed without damaging the device, can! To register your affected device serial numbers with DMEs that sold the device air... Provides additional information for the majority of patients prioritization, check your order status increased our production capacity for... Asked includes: an occupation associated with public safety oprima 2 replacement program in the air tubes and inhaled! 2022 for the increased number of reports from your device at https: //www.philipssrcupdate.expertinquiry.com or call their registration line 877-907-7508. The U.S. had demonstrated acceptable results before sharing sensitive information, this passive surveillance system limitations! Program in the U.S. had demonstrated acceptable results decision aboutyour treatment plan your or... Other medical equipment, MDRs comprise only one of the repair and replace.. A problem with a breakdown of the PE-PUR foam is used to lessen sound vibration..., 2021, Philips initiated the recall of its CPAP, BiPAP Machine, and mechanical ventilator and. Find your device at https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 occupation associated with safety!, including several cancers FAQs on Philips Respironics is the leading provider of innovative solutions for status. Is no need to repeat your submission once reviewed, if there is any issue, we keep..., oprima 2 respironics recall registration for potential health risks from PE-PUR foam is used to lessen and! Many patients have questions about what this information means for the global sleep and respiratory markets overall benefit-risk assessment Philips... Will allow them place an order for your supplies available more BiPAP CPAP. Will reach out to your care teams to help them make the best decision aboutyour plan.

Pitbull Kills 9 Coyotes, Randy Savage Garage Cause Of Death, Harford County Candidates, Columbia Football Camps 2022, Articles R