2. 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. Access all your product information in one place (orders, subscriptions, etc. 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. endstream endobj startxref It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. All rights reserved. Please call us so we can get your question routed to the team that can best assist you with your issue. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. 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. Secure .gov websites use HTTPS 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. Philips Respironics has issued a . 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. All rights reserved. You can log in or create one. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. You are about to visit a Philips global content 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. For any therapy support needs or product questions please reach out hereto find contact information. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. All rights reserved. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. 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. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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. By returning your original device, you can help other patients. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. * This is a recall notification for the US only, and a field safety notice for the rest of the world. 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. To enter and activate the submenu links, hit the down arrow. 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: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Identifying the recalled medical devices and notifying affected customers. 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. Before sharing sensitive information, make sure you're on a federal government site. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. Our Prescription Team is required to review all prescriptions. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Why do I need to upload a proof of purchase? 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). 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. Create account Create an account Already have an account? 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. Membership. 1. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. b. The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. If you have already consulted with your physician, no further action is required of you withregards to this update. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. All rights reserved. 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. 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 Respironics created an online registration process to allow patients to look up their device serial number . Apologize for any inconvenience. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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 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. 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 you have already consulted with your physician, no further action is required of you withregards to this update. 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. 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. Lock Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. An official website of the United States government. Hit enter to expand a main menu option (Health, Benefits, etc). The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. have hearing loss. A locked padlock 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. I need to change my registration information. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. For patients using life-sustaining ventilation, continue prescribed therapy. In this video, we will be going into detail about the process to register your device on the Philips website. 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. 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. 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. 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. 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. Overview. 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. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. You can also upload your proof of purchase should you need it for any future service or repairs needs. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. This will come with a box to return your current device to Philips Respironics. We may request contact information, date of birth, device prescription or physician information. CHEST Issues Joint Statement in Response to Philips Device Recall . 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. The .gov means its official.Federal government websites often end in .gov or .mil. Images may vary. 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. Philips Respironics Sleep and Respiratory Care devices, 2. 2. Can we help? A lock ( At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. 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. No. If you have completed this questionnaire previously, there is no need to repeat your submission. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. 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. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + 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. It may also lead to more foam or chemicals entering the air tubing of the device. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Call us at +1-877-907-7508 to add your email. You are about to visit the Philips USA website. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. The relevant heath information that will be asked includes: An occupation associated with public safety. 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 . 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? a. You may have to contact your care provider to program the device to your prescribed settings. secure websites. 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. Team share the most up-to-date information an account understand the DreamStation 2 and Trilogy EVO machines are not included the! Machines and respirators on June 14, 2021 * the number of deaths been. 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