What do I do? Philips Respironics, Inc., is recalling its Continuous and Non-Continuous Ventilators due to the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, which may break down and potentially enter the devices air pathway. Philips will replace the PE-PUR foam sound abatement component with the new silicone foam sound abatement component in the affected devices to correct in the field. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). By returning your original device, you can help to make sure that it can be repaired for future use by another patient. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Please be sure to check philips.com/src-update for the latest information on remediation progress. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Repair and Replacement On Sept. 1, Philips announced that it had received authorization from the FDA to begin its repair and replacement programs for recalled devices. Depending on the device, the CPAPs, BiPAPs, and ventilators may be used in the home, hospital and other institutional settings. Please click. It is important that you do not stop using your device without discussing with your doctor. If you had a CPAP machine before you got Medicare, you will need to check with Medicare to see if you qualify for certain requirements that will cover the cost of the replacement of your machine. If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at https://www.mdl3014preservationregistry.com, Philips will not charge the users DME supplier for the cost of the replacement device. If this occurs, black debris from the foam or certain chemicals released into the devices air pathway may be inhaled or swallowed by the person using the device. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. 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 have completed all steps with Philips Respironics currently available to help our customers move forward in the process. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. The .gov means its official.Federal government websites often end in .gov or .mil. In a May 16 news announcement, parent company Royal Philips said, "The risk assessments . Connecting patients and care teams, DreamStation devices empower users to embrace their care with confidence, and enable care teams to practice efficient and . Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. They do not include user serviceable parts. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Devices affected by the recall / field safety notice must be serviced only by qualified technicians. A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. Please, In December 2022, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. The latest information regarding this action can be found at our publicly available web site: https://www.philips.com/src-update. By Lisa Spear (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP device.). With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of . Using packing tape supplied, close your box, and seal it. To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected. In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Each day more information becomes available. Ozone cleaners may worsen the breakdown of the foam, and there are other. Health care providers and in-home caregivers who provide care for patients who use DreamStations for breathing support. This means the recalled product may cause serious injury or death. For the latest information on remediation of Trilogy 100/200 please click here to visit our ventilation news and updates page. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use. Once all accessories have been installed, plug in your device to a working wall outlet and wait five minutes for your device settings to upload. Heres How to Get Low-Cost or Free CPAP Supplies! You are about to visit a Philips global content page. It does not apply to DreamStation Go. I have seen foam repair kits offered online at Amazon.com and elsewhere from third parties. 144 Donald Camp of Falls Church, Va., uses a continuous positive air pressure device to combat his sleep apnea. This Philips Respironics December 2022 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for VOCs, particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products. Your prescription pressure should be delivered at this time. Those who have Medicare are in a similar case-by-case situation. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. They can help you if you have questions about how to use your replacement device and can troubleshoot and document issues you may be having. As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. 1800-28-63-020. As we continue to work through the voluntary recall, we assure you that we are fully committed to supporting all patients and will continue to partner with clinicians and business customers to complete recall efforts. The DreamStation can provide both continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) support. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or "806 report") in June 2021. On February 10, 2023, Philips sent affected customers and patients an Important Product Notice with the following recommendations: Philips is attempting to contact all users and/or patients by phone to set up pressure changes or replacement and return of affected devices. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. The advocacy demonstrated by the AASM has not been confirmed as a solution from CMS, however, so the best course of action is to call your Medicare or Medicaid provider directly regarding new sleep studies, reimbursement for repair costs, or the issuance of a new device. You can read the press release here. 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. You do not need to register your replacement device. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. As we continue to work through the voluntary recall, we assure you that we are fully committed to supporting all patients and will continue to partner with clinicians and business customers to complete recall efforts. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. The website provides current information on the status of the recall and how to receive permanent corrective action to address the issues. As a result, testing and assessments have been carried out. Before sharing sensitive information, make sure you're on a federal government site. The exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. As a result, testing and assessments have been carried out. What is the status of the Trilogy 100/200 remediation? By returning your original device, you can help to make sure that it can be repaired for future use by another patient. On Monday, June 14th, Philips Respironics issued a voluntary recall on nearly all of their CPAP, APAP, and BiPAP machines sold from 2009 until today, with some exceptions. Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of replacement of the PE-PUR sound abatement . After youve registered your machine with Philips, you may be asking, what are my options for continuing therapy while I wait for Philips to send me a replacement machine or repair kit? For those who cannot currently afford new equipment but who have been encouraged to continue their sleep apnea treatment, weve included a few solutions at the end of this article that we hope can be beneficial to you. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series), Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US), Also known as BiPAP V30 Auto Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. In December 2022, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. We stand by, ready to help Philips Respironics technologically or logistically if needed to quicken getting help to our customers.