Is there a question we can answer for you? Where do I direct questions about my replacement device? 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). 4. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). Contact your clinical care team to determine if a loan device is required. If you have not done so already, please click here to begin the device registration process. We thank you for your patience as we work to restore your trust. We know how important it is to feel confident that your therapy device is safe to use. The complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. Do affected units exhibit features that customers / users should watch out for? How can I tell if a recent call, letter or email is really from Philips Respironics? We know how important it is to feel confident that your therapy device is safe to use. If you do not have this letter, please call the number below. The complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall, In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending, In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. For further information please contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. Philips may work with new patients to provide potential alternate devices. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. [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. No further products are affected by this issue. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. ~90%production and 80% shipment of recall units, Encouraging test results for DS1platform (within safety norms), 483remediation and clarity on proposed Consent Decree, Driving patient engagement and registrations with dedicated registration system and infrastructure Continued patient outreach through mailing, call center, websites and direct contact with interest groups Comprehensive DME outreach Met the requirements in FDA's 518(a) order and continue to report progress Ongoing engagement with regulators to optimize the recall efforts Sharing progress on testing program to ensure patients and physicians fully informed, The task at hand Around 5.5M devices expected to berepaired or replaced Equivalent to over 5x previous annualproduction volume >1 thousand new product configurationsreleased globally Partnering with DMEs for patientdelivery, Progress to date Quadrupledproduction capacity compared to pre-recall >1,000people cross functional team engaged Dependencyon supply of materials and global logistics capacity ~90% production and 80% shipment of recall units in 2022, VOCtesting Emissions within ISO limits(devices not exposed to ozone) Visualinspection and assessment of the foam in used devices Lowprevalence of significant visible foam degradation Evenwhen significant visible particulates are formed, likely to accumulate insidethe device ParticulateMatter testing Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits Bioassayevaluation, chemical characterization and toxicological risk assessment Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Emissions within ISO limits(devices not exposed to ozone), Visualinspection and assessment of the foam in used devices, Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits, Bioassayevaluation, chemical characterization and toxicological risk assessment, Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Finalizetoxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in DreamStation1 devices Expected in Q2 2023 Completetesting for SystemOne(~26% of registered devices) and DreamStationGo (~1%), which contain the exact same foam as the DreamStation1 devices Expected in Q2 2023 CompleteVOC and PM testing, as well as chemical evaluation and toxicologicalassessments for Trilogy 100/200 (~3%) and OmniLab(~2%), where a different PE-PUR foam is used Expected in Q3 2023 Ongoingengagement with FDA and other competent authorities, There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click here for more details Two of the studies[1] [2]showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). 3. 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). Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. However, this new recall does apply to some of the devices recalled . 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. 1800-28-63-020. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Philips CPAPs cannot be replaced during ship hold. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Discuss the best treatment course with the patient. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click, Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations, Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis, In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. . 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. If your physician determines that you must continue using this device. This Alert was related only to Trilogy 100 ventilators that were repaired. 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. 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. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. What is the cause of this issue? After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Was it a design, manufacture, supplier or other problem? Philips Australia will work with your clinical care team to arrange a loan device, where required. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? High heat and high humidity environments may also contribute to foam degradation in certain regions. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: For patients using life-sustaining mechanical ventilator devices: The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Images may vary. Why did Philips issue the global recall notification in June 2021? Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. Register your device (s) on Philips' recall website . Are affected devices continuing to be manufactured and/or shipped? The relevant subsidiaries are cooperating with the agency. If separation of the foam from the plastic backing was to occur, to the extent that therapy is impacted, your device will issue a High Priority alarm, either Low Inspiratory Pressure or Circuit Disconnect. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Membership. The letter offered the following recommendations. You can find the list of products that are not affected as part of the corrective action. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). If you have a secondary back up device, switch over to that device. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). All oxygen concentrators, respiratory drug delivery products, airway clearance products. How did this happen, and what is Philips doing to ensure it will not happen again? Patient safety is our top priority, and we are committed to supporting our . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. What is the safety hazard associated with this issue? High heat and high humidity environments may also contribute to foam degradation in certain regions. 2. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. You are about to visit the Philips USA website. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). 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. Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The following updates in relation to device testing have been released by Philips RS North America on this webpage: Please note that the Philips RS North America website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia. 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. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. kidneys and liver) and toxic carcinogenic affects. Replace these devices with an unaffected device. 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. Doing this could affect the prescribed therapy. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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 . 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. Can I trust the new foam? However, this new recall does apply to some of the devices recalled in June 2021. Additional Resources: Medical Device Recall. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. 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. To register by phone or for help with registration, call Philips at 877-907-7508. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. Begin registration process 877-907-7508 News and Updates > Important update to Philips US recall notification Important update to Philips US recall notification November 16, 2021 Philips has updated the US recall notification to align with the FDA's recommendation in connection with these recalls and provide broader guidance on use. The following products listed are affected by the correction: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Information for Trilogy 100 patients with a repaired device. Can we help? If you have a secondary back up device, switch over to that device. All patients who register their details will be provided with regular updates. Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. All rights reserved. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). Process 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 anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. To referring to the instructions if there is an EMERGENCY, you must call 000.! 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