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. Membership. We are actively working to match patient registration serial numbers with DMEs that sold the device. 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. 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. classified by the FDA as a Class I recall. See all support information 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Philips Respironics has issued a . You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. There are currently no items in your shopping cart. 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. 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. 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. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Koninklijke Philips N.V., 2004 - 2023. Apologize for any inconvenience. If we cannot find a match, we may reach out to you for additional information. You must register your recalled device to get a new replacement device. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. All rights reserved. Once your order is placed the order number will be listed in the Patient Portal. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. For further information about your current status, please log in to the. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. If you are in crisis or having thoughts of suicide, We will automatically match your registered device serial number back to our partner inventory registrations. Call us at +1-877-907-7508 to add your email. 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. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. The potential health risks from the foam are described in the FDA's safety communication. Lock Dont have one? Before sharing sensitive information, make sure you're on a federal government site. Before sharing sensitive information, make sure you're on a federal government site. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. Medical guidance regarding this recall. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. Consult with your physician as soon as possible to determineappropriate next steps. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Selected products When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. For further information about your current status, please log into the portal or call 877-907-7508. To access the menus on this page please perform the following steps. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Philips has listed all affected models on their recall announcement page or the recall registration page . We will keep the public informed as more information becomes available. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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. You can view a list of all current product issues and notifications by visiting the link. the .gov website. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. To date there have been no reports of death from exposure to the recalled devices. The full report is available here. Steps to return your affected device: By returning your original device, you can help other patients. The FDA's evaluation of the information provided by Philips is ongoing. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? You are about to visit a Philips global content page. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. The full report is available here. secure websites. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Philips Respironics Sleep and Respiratory Care devices, 2. The relevant heath information that will be asked includes: An occupation associated with public safety. 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. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. 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. 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + You are about to visit a Philips global content page. To enter and activate the submenu links, hit the down arrow. 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 known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. Foam: Do not try to remove the foam from your device. Secure .gov websites use HTTPS 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. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. 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. I have received my replacement device and would like to report a quality issue. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Register your product and start enjoying benefits right away. 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. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. No. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. The full report is available here. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) All rights reserved. %%EOF There are no updates to this guidance. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . That will allow them place an order for your supplies. How can I register my product for an extended warranty? At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. a. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. You may or may not see black pieces of the foam in the air tubes or masks. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Call us at +1-877-907-7508 to add your email. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. 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. Not yet registered? 272 0 obj <> endobj You can still register your device on DreamMapper to view your therapy data. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Trying to or successfully removing the foam may damage the device or change how the device works. 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. Log in This update provides additional information on the recall for people who use repaired and replaced devices. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 22 Questions At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. You are about to visit the Philips USA website. benefits outweigh the risks identified in the recall notification. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. 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. 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. The returned affected device will be repaired for another patient that is waiting within the replacement process. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Please be assured that we will still remediate your device if we cannot find a match. Have the product at hand when registering as you will need to provide the model number. Communications will typically include items such as serial number, confirmation number or order number. We may request contact information, date of birth, device prescription or physician information. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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? 1. The FDA has reached this determination based on an overall benefit-risk assessment. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . 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. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. 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. In the US, the recall notification has been. You can still register your device on DreamMapper to view your therapy data. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. Consult with your physician as soon as possible to determineappropriate next steps perform the following steps 's benefit-risk.. To prevent permanent injury devices for Veteran with our partners to determine the best way to or! 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