A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Replace these devices with an unaffected device. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). People who receive breathing support from the affected Philips BiPAP (ventilator) machines. The potential risks associated with this recall include: If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. After registration, we will notify you with additonal information as it becomes available. Where do I direct questions about my replacement device? However, this new recall does apply to some of the devices recalled in June 2021. The company has developed a comprehensive plan for this correction, and has already begun this process. When will the correction for this issue begin? For more information on the recall notification for customers, users and physicians, please click here. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . See all support information The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. Click the link below to begin our registration process. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. Are affected devices safe for use? Stopping treatment suddenly could have an immediate and detrimental effect on patient health. 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 Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. Follow those instructions. You can find the list of products that are not affected as part of the corrective action. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. As part of the notification process, customers and patients will be provided with more information on the next steps to implement the solution as it becomes available. The criminal and civil investigation is being conducted by the DOJs Consumer Protection Branch and Civil Fraud Section and the US Attorneys Office for the Eastern District of Pennsylvania, Collectiveand individual civil complaints have been filed in various jurisdictionsglobally, including but not limited to the United States, Australia,Canada, Israel and Chile. Why did Philips issue the global recall notification in June 2021? At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. Are you still taking new orders for affected products? The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. You can access the Philips RS North America webpage by clicking here. This Alert was related only to Trilogy 100 ventilators that were repaired. Call us at +1-877-907-7508 to add your email. Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. 1. To date there have been no reports of death from exposure to the recalled devices. . You are about to visit the Philips USA website. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. On June 14th, 2021, Philips Respironics released a safety communication statement that they will be issuing a device recall for almost all of their machines sold from 2009 to the present day. We are in touch with relevant customers and patients. For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. (0044) 20 8089 3822 Physicians and other medical care providers Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. All rights reserved. This potentially deadly combination . Testing is ongoing and you can obtain further information about the testing and matters relating to the recall from the device manufacturer, Philips RS North America LLC. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) DreamStation Go With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. The recall is a high-profile problem that has affected millions of patients in the U.S. and other countries for almost two years, and those . How are you removing the old foam safely? 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. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). Philips Australia will work with your clinical care team to arrange a loan device, where required. Always ensure you are being taken care of, i.e. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and corrected devices is a silicone foam. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Philips is notifying regulatory agencies in the regions and countries where affected products are available. [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. Click the link below to begin our registration process. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. The new material will also replace the current sound abatement foam in future products. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. If your physician determines that you must continue using this device. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. Medical Device recall notification (U.S. only) / field safety notice (International Markets). * Voluntary recall notification in the US/field safety notice for the rest of the world. You are about to visit the Philips USA website. The products were designed according to, and in compliance with, appropriate standards upon release. Overview. All rights reserved. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. kidneys and liver) and toxic carcinogenic affects. The return shipment for your old device is pre-paid so there is no charge to you. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). 2) the PE-PUR foam may off-gas certain chemicals. The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. Philips will be moving to dismiss theSecond Amended Complaint, Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters, Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues, These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers, The FDA acknowledges that the submission of an. The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. Additional Resources: Medical Device Recall. Do affected units exhibit features that customers / users should watch out for? Updating everyone on what they need to know and do, and to participate in the corrective action. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. If you have a secondary back up device, switch over to that device. What is the cause of this issue? June 2021: 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; Philips Respironics initiated a voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). Patients who are concerned should check to see if their device is affected by the corrective action. 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). The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. The device types are: For patients who registered their DreamStation Go, Philips Australia commenced the replacement program for DreamStation Go devices in December 2022 and it will continue into Q1 2023. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. Please note that the information available at these links has not been separately verified by Philips Australia. Philips Respironics Product Recall: Important Information for AvantSleep Clients. Selected products For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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