2. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. The return shipment for your old device is pre-paid so there is no charge to you. 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. 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. 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. 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. 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. 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. Philips Quality Management System has been updated to reflect these new requirements. Please note, the correction for Trilogy 100 is currently on hold. Follow those instructions. Overview. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. 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 Quality Management System has been updated to reflect these new requirements. 1. 1. Are you still taking new orders for affected products? 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. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. The recall includes many mechanical ventilator . You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. For Spanish translation, press 2; Para espaol, oprima 2. . [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. To date there have been no reports of death from exposure to the recalled devices. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use. Is Philips certain that this issue is limited to the listed devices? Additional Resources: Medical Device 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. 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. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. The issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration. 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. Select your country. Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. 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. 2. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. After registration, we will notify you with additonal information as it becomes available. 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. Is there any possibility others are affected? Call 1800-28-63-020 if you cannot visit the website or do not have internet access. High heat and high humidity environments may also contribute to foam degradation in certain regions. 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. 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. 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. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. 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. 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. BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. All rights reserved. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 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. Go to www.philips.com/src-update and click on "Begin registration process" (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process") Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas) What happens after I register my device, and what do I do with my old device? 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. [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. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. 3. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. The relevant subsidiaries are cooperating with the agency. 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. The company has developed a comprehensive plan for this correction, and has already begun this process. We thank you for your patience as we work to restore your trust. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). You are about to visit the Philips USA website. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway. What is meant by "high heat and humidity" being one of the causes of this issue? Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. The device types are: 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) 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. kidneys and liver) and toxic carcinogenic affects. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). What is the cause of this issue? Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio. 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 . 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. Please note, the correction for Trilogy 100 is currently on hold. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Philips has been in full compliance with relevant standards upon product commercialization. Are affected devices being replaced and/or repaired? No further products are affected by this issue. If you have a secondary back up device, switch over to that device. Plaintiffsfiled a Second Amended Complaint in November 2022. Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a claim if their unit is affected. Contact your clinical care team to determine if a loan device is required. Once you receive your replacement device, you will need to return your old device. We thank you for your patience as we work to restore your trust. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Is there a question we can answer for you? 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