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. the .gov website. 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. 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. Secure .gov websites use HTTPS 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. Dont have one? On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Call us at +1-877-907-7508 to add your email. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. You can create one here. Koninklijke Philips N.V., 2004 - 2023. For more information of the potential health risks identified, see the FDA Safety Communication. Please call our registration line or visit our registration website. Why do I need to upload a proof of purchase? These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 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 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Apologize for any inconvenience. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. ) or https:// means youve safely connected to If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 272 0 obj <> endobj 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. Log in I need to change my registration information. We recommend you upload your proof of purchase, so you always have it in case you need it. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . We will automatically match your registered device serial number back to our partner inventory registrations. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. 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. Consult with your physician as soon as possible to determineappropriate next steps. I have general DreamMapper questions or DreamMapper connection issues. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. 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. Philips Respironics Sleep and Respiratory Care devices, 2. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. 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. Trying to or successfully removing the foam may damage the device or change how the device works. A lock ( If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Share sensitive information only on official, Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. organization in the United States. Koninklijke Philips N.V., 2004 - 2023. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. b. 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. 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. 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. 1. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. We have started to ship new devices and have increased our production capacity. Attention A T users. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. In the US, the recall notification has been classified by the FDA as a Class I recall. Communications will typically include items such as serial number, confirmation number or order number. Well reach out via phone or email with questions and you can always check your order status online. 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: . It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Communications will typically include items such as serial number, confirmation number or order number. 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. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Keep your registration confirmation number. 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. 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. 2. 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. For Spanish translation, press 2; Para espaol, oprima 2. Veterans Crisis Line: On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. The full report is available here. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Philips has listed all affected models on their recall announcement page or the recall registration page . Consult with your physician as soon as possible to determineappropriate next steps. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Then you can register your product. Follow the recommendations above for the recalled devices used in health care settings. 2. Eight of those reports were from the U.S. We may request contact information, date of birth, device prescription or physician information. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. A breakdown of the foam may damage the device 's air tubes and inhaled!, along with data from other sources, can contribute important information to a device... With a breakdown of the foam material used for sound reduction in CPAP! 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