The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. Philips Australia will work with your clinical care team to arrange a loan device, where required. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. Koninklijke Philips N.V., 2004 - 2023. Consult your Instructions for Use for guidance on installation. Updating everyone on what they need to know and do, and to participate in the corrective action. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. 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. 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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. 2) the PE-PUR foam may off-gas certain chemicals. 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 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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. 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 following products listed are affected by the correction: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Information for Trilogy 100 patients with a repaired device. Patient safety is our top priority, and we are committed to supporting our . As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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. Please note that the information available at these links has not been separately verified by Philips Australia. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Philips Australia will work with your clinical care team to arrange a loan device, where required. Please note, the correction for Trilogy 100 is currently on hold. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. 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. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). All rights reserved. The company has developed a comprehensive plan for this correction, and has already begun this process. Koninklijke Philips N.V., 2004 - 2023. Call us at +1-877-907-7508 to add your email. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) are used in clinical environment and home care settings, If the device was not already corrected or replaced through the June 2021 recall. Register your device (s) on Philips' recall website . Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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. All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. If their device is affected, they should start theregistration process here. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. We know how important it is to feel confident that your therapy device is safe to use. If your physician determines that you must continue using this device. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. If you have not done so already, please click here to begin the device registration process. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Consult with your physician as soon as possible to determine appropriate next steps. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. The application for discontinuance will be heard by the Federal Court on 3 April 2023. You are about to visit the Philips USA website. The plastic may also cause the machine to fail and stop working suddenly during use. In the event of exposure to chemical emissions: The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. Always ensure you are being taken care of, i.e. https://doi.org/10.1183/13993003.00551-2022, Continued patient outreach through mailing, call center, websites and direct contact with interest groups, Met the requirements in FDA's 518(a) order and continue to report progress, 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, 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, Lowprevalence of significant visible foam degradation, Evenwhen significant visible particulates are formed, likely to accumulate insidethe device, 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, 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. *Note*: You can also call 877-907-7508 to register your device. Additional Resources: Medical Device Recall. 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. kidneys and liver) and toxic carcinogenic affects. 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. Leandro Mazzoni Head of Investor Relations, Rashiq Muhaimen Investor Relations Manager ESG related topics, Investor Relations Manager ESG related topics, Monique van der Heiden Corporate Access Manager. This potentially deadly combination . By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: 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 with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Theremediation of this field safety notice is underway and has started for the following devices: Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. 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