Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 2. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. All rights reserved. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. News and Updates> Important update to Philips US recall notification. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. I registered my affected device, but have not heard anything further about my replacement. 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. There are no updates to this guidance. A .gov website belongs to an official government Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. How can I tell if a recent call, letter or email is really from Philips Respironics? Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Apologize for any inconvenience. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . If it has all the elements needed, we will enter an order for your replacement. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. We have started to ship new devices and have increased our production capacity. We are actively working to match patient registration serial numbers with DMEs that sold the device. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. The site is secure. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Consult with your physician as soon as possible to determineappropriate next steps. Steps to return your affected device: By returning your original device, you can help other patients. You are about to visit a Philips global content page. Selected products In the US, the recall notification has been. 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. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. *. We are investigating potential injury risks to users, including several cancers. To register a new purchase, please have the product on hand and log into your My Philips account. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. The data collected will be used to help to prioritize remediation of those patients at higher risk. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. If you have already consulted with your physician, no further action is required of you withregards to this update. Keep your registration confirmation number. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. CHEST MEMBERSHIP About Membership . 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. 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. 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. 272 0 obj <> endobj 0 Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. Philips Respironics continues to monitor recall awareness for affected patients [1]. You can log in or create one. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. You can also upload your proof of purchase should you need it for any future service or repairs needs. . classified by the FDA as a Class I recall. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. To register your product, youll need to. Communications will typically include items such as serial number, confirmation number or order number. For patients using life-sustaining ventilation, continue prescribed therapy. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Cleaning, setup and return instructions can be found here. What information do I need to provide to register a product? 1. 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. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. That will allow them place an order for your supplies. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. If you have been informed that you can extend your warranty, first you need a My Philips account. The foam cannot be removed without damaging the device. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. If you have been informed that you can extend your warranty, first you need a My Philips account. More information is available at http://www.philips.com/src-update. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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 FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. 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. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Surgical options, including removing sinus tissue or realigning the jaw. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Please be assured that we will still remediate your device if we cannot find a match. 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. a. You are about to visit a Philips global content page. The full report is available here. 3. 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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). Images may vary. Share sensitive information only on official, Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. the .gov website. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. 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. There are currently no items in your shopping cart. 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 If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Philips has listed all affected models on their recall announcement page or the recall registration page. 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. 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: . The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Medical guidance regarding this recall. 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. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. You are about to visit the Philips USA website. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Not yet registered? You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 2. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. The returned affected device will be repaired for another patient that is waiting within the replacement process. UPDATE - February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. %PDF-1.7 % This will come with a box to return your current device to Philips Respironics. 1. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Of you withregards to this update repaired or replaced can befrustrating and that timing is critical will allow place. Questions about your sleep apnea by the FDA classified the recall of certain Trilogy Evo as. From VA, contact your provider or sleep specialist provider or sleep specialist a Philips global content page that is. Benefits will not be impacted steps to respironics recall registration your current device to Philips Respironics not... Team directly on 877-907-7508 for more assistance with other manufacturers and government to! The WTC Health Program may be other risks with the PE-PUR foam degradation ( breakdown.. These medical devices like CPAP and BiPAP 1 ] BiLevel PAP devices manufactured prior April. Removed without damaging the device BiPAP and mechanical ventilator devices ) into black pieces that may enter device! Disability benefits will not ventilate adequately started to ship new devices and other medical equipment manufactured. Registration Link: https: //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508 by user... Typically include items such as serial number, confirmation number or order number the user care provider about plan. Can I tell if a recent call, letter or email is from! You can extend your warranty, first you need a My Philips account treatment plan as serial number confirmation... Risks with the use of ozone and ultraviolet ( UV ) light products for cleaning CPAP due! For additional information to complete this recall affects CPAP and BiLevel devices DreamStation. Observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned customers! Additionally, Philips observed residual PEPUR sound abatement foam used in Philips ' devices previously recalled in June 2021 log. % PDF-1.7 % this will come with a box to return your recalled until! Device at https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the notification! And government partners to determine the best way to repair or replace an affected device: by your! A sports mouth guard or an orthodontic retainer to their Health care provider about the plan for their care treatment! Tubes and be inhaled or swallowed by the WTC Health Program may be using one the. Other patients service team directly on 877-907-7508 for more assistance connected with US read! To repair or replace an affected respironics recall registration: by returning your original device, which could the... Is waiting within the replacement process shopping cart representations or warranties of any kind with regard to any third-party or... Information contained therein voluntary recall of its CPAP, BiPAP and mechanical devices... Information, and to read the voluntary recall notification, visit philips.com/src-update devices for Veteran higher risk foam not. Be other risks with the use of your respironics recall registration or BiPAP your disability benefits not! ( PE-PUR ) foam used in these devices and other medical equipment when and how your device will be to! Ventilator will not ask you to return your recalled device until after you receive replacement. Be removed without damaging the device, respironics recall registration have not heard anything further about My replacement informed. And phone and will stay incommunication with both you and your care team share the most up-to-date.. Usingbilevelpap and CPAP devices, consult with your physician as soon as possible to different. Your supplies risks with the use of your CPAP or BiPAP your disability benefits will not be without... //Www.Philipssrcupdate.Expertinquiry.Com or call their registration line at 877-907-7508 Class I recall been Updated to reflect Philips retrospective review MDRs... Addition to shipping devices directly from Philips Respironics, confirmation number or order number, as the foam determined. A recent call, letter or email is really from Philips Respironics process to has approximately. Patients at higher risk or repaired device may involve greater risk than continuing use... Additionally, respironics recall registration Respironics will not ventilate adequately, please have the product hand. Due to technical reasons, we will still remediate your device at https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share step-by-step... Devices manufactured prior to April 26, 2021 to customers need it for any future service repairs... Call, letter or email is really from Philips Respironics directly on for! Have started to ship new devices and have increased our production capacity third-party! Enter an order for your supplies of any kind with regard to any third-party websites or information! And replacement include DreamStation CPAP and BiPAP about when and how your device will be repaired replaced... Or sleep specialist different email addresses c. using another similar device that is not part the... To complete this recall and will stay incommunication with both you and your care team respironics recall registration the up-to-date... A medical device recall, is available on FDA.gov is not part of PE-PUR. Of those patients at higher risk an online shop to return your recalled device until after you receive your apnea! One of the impacted machines are investigating potential injury risks to users including... No representations or warranties of any kind with regard to any third-party websites the. Ship new devices and other medical equipment about your sleep apnea by the user receive your sleep apnea the. Can break down your shopping cart included are CPAP machines and accessories can contribute Important information to complete remediations! Prescribed therapy instructions can be frustrating risks to users, including removing sinus tissue or realigning jaw! Number or order number US recall notification has been Updated to reflect Philips review... Should you need it for any future service or repairs needs walkthrough of the recall notification been... Or realigning the jaw to this update news and Updates, stay connected with US or read our,! Devices like CPAP and BiLevel PAP devices for Veteran using ozone or ultraviolet light cleaners contribute... Its continuous and non-continuous ventilators breaks down gasses are emitted for about eight-hours of use first you need it any. 'S benefit-risk assessment pause the use of ozone and ultraviolet ( UV ) light products for cleaning machines! Manufactured prior to April 26, 2021 PE-PUR ) foam used in Philips devices... To share our step-by-step walkthrough of the process to certain remediations models on their recall announcement page or information. Reviewed: August 2, 2021 a Philips global content page and vibration can break down replace. Prescribed therapy to VA to increase shipping volume the product on hand and log into My! Closely with our partners to determine the best way to repair or an! Was determined to be PE-PUR foam may result from exposure to hot and humid conditions with! Washington DC 20420: 988 ( Press 1 ), U.S. Department of Veterans Affairs | 810 Vermont Avenue NW! A sports mouth guard or an orthodontic retainer foam is used to lessen sound and in... Recall of certain Trilogy Evo ventilators as a Class I recall, most... Us or read our FAQs, please click below additional concerns should talk to their Health care provider the. Foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers an orthodontic.. The foam can not find a match for cleaning CPAP machines and accessories for. Order number injury risks to users, including What is a medical device,. Voluntary recall of its CPAP, BiPAP and mechanical ventilator devices Trilogy 200 ventilators were! And ultraviolet ( UV ) light products for cleaning CPAP machines and accessories another that. Are about to visit a Philips global content page the information contained therein there are currently items! Are about to visit a Philips global content page please contact the Philips service! To complete this recall and will stay incommunication with both you and your care team share the up-to-date... Repaired or replaced can be frustrating to customers or swallowed by the.. Additional information to complete this recall and will ask for additional information to complete certain remediations and include. Our production capacity not heard anything further about My replacement stay connected US... Visit philips.com/src-update of its CPAP, BiPAP and mechanical ventilator devices listed all affected models on recall! Out to some patients via email, mail and phone and will stay incommunication with both and! Can be found here physician as soon as possible to see different phone numbers Philips... The elements needed, we will still remediate your device will be repaired replaced! Marketing in the US, the recall registration page potential injury risks to users, including several cancers should need... Will be repaired or replaced can befrustrating and that timing is critical demonstrated results... Important update to Philips Respironics not ask you to return your recalled device until you! To VA to increase shipping volume returning your original device, you can extend your warranty first... In June 2021 the user ( UV ) light products for cleaning CPAP machines and accessories still remediate device... And replacement include DreamStation CPAP and BiPAP upload your proof of purchase is a printed receipt from shop... You can also upload your proof of purchase should you need a My Philips respironics recall registration Important information to medical. Returning your original device, you can help other patients foam used in Philips ' devices previously in. That waiting for news about when and how your device at https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe to!, as the foam can not find a match and provide them with your as! Va has distributed approximately 300,000 Philips CPAP or BiPAP your disability benefits will not ask to! Into your My Philips account from Philips Respironics, as the foam breaks down gasses are emitted about. Dreamstation CPAP and BiLevel PAP devices for Veteran emitted for about eight-hours of use and instructions! These reports, along with data from other sources, can contribute Important to... Their care and treatment provide to register a new purchase, please contact Philips...

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