Doing this could affect the prescribed therapy. We thank you for your patience as we work to restore your trust. 4. 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. 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. This recall notification / field safety notice has not yet been classified by regulatory agencies. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. Membership. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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 may work with new patients to provide potential alternate devices. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. 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). The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. 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. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Register your device at the Phillips Respironics website (link below). Is there any possibility others are affected? On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. You can find the list of products that are not affected as part of the corrective action. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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. If you do not have this letter, please call the number below. 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. Koninklijke Philips N.V., 2004 - 2023. 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). 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. This recall notification / field safety notice has not yet been classified by regulatory agencies. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Can I trust the new foam? Click "Next". No further products are affected by this issue. 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. Call us at +1-877-907-7508 to add your email. 14841488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. 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. Plaintiffsfiled a Second Amended Complaint in November 2022. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. However, this new recall does apply to some of the devices recalled in June 2021. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. Register your device (s) on Philips' recall website . Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. To register your device and check if your machine is included in the recall: Locate the serial number of your device. If you have a secondary back up device, switch over to that device. [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. If your physician determines that you must continue using this device. You can find the list of products that are not affected as part of the corrective actionhere. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. 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. Patient safety is our top priority, and we are committed to supporting our . Are affected devices continuing to be manufactured and/or shipped? 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. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. Once you receive your replacement device, you will need to return your old device. 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. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. Don't have one? In the event of exposure to degraded foam: The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. 1. Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. 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. When will the correction for this issue begin? Patients who are concerned should check to see if their device is affected by the corrective action. Philips has been in full compliance with relevant standards upon product commercialization. Only machines with serial numbers identified in the companys communications are affected by this recall. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. At the bottom of this website, click Patient/Device User . The application for discontinuance will be heard by the Federal Court on 3 April 2023. 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. Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS 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. This information has not been separately verified by Philips Electronics Australia Ltd. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. 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. 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. Philips Sleep and respiratory care. The relevant subsidiaries are cooperating with the agency. 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). After registration, we will notify you with additonal information as it becomes available. 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. 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 Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Philips CPAPs cannot be replaced during ship hold. 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. 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. As a first step, if your device is affected, please start the. Do affected units exhibit features that customers / users should watch out for? 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