For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Philips CPAP Recall Information. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Before sharing sensitive information, make sure you're on a federal government site. You can register here. 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. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. The letter offered the following recommendations. Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. If their device is affected, they should start theregistration process here. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Philips is notifying regulatory agencies in the regions and countries where affected products are available. As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. kidneys and liver) and toxic carcinogenic affects. Koninklijke Philips N.V., 2004 - 2023. Replace these devices with an unaffected device. 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. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. You are about to visit a Philips global content page. 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 will provide further updateson the remediation of this field safety notice, including updates on other affected models. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. 3. 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. 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). You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Do affected units exhibit features that customers / users should watch out for? Register your device (s) on Philips' recall website . For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. 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. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. This could affect the prescribed therapy. 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. Follow those instructions. 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. 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) Will existing patient devices that fail be replaced? 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. 2) the PE-PUR foam may off-gas certain chemicals. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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). Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. This recall notification / field safety notice has not yet been classified by regulatory agencies. The new material will also replace the current sound abatement foam in future products. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. At the bottom of this website, click Patient/Device User . For more information on the recall notification for customers, users and physicians, please click here. 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. 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. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. See all support information 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. Have regulatory authorities classified the severity of the recall? We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. If you have a secondary back up device, switch over to that device. How did this happen, and what is Philips doing to ensure it will not happen again? All rights reserved. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We thank you for your patience as we work to restore your trust. 1. Can we help? Are there any steps that customers, patients, and/or users should take regarding this issue? 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. 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. - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. 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. Do not stop or alter your prescribed ventilator therapy. On June 14, Philips issued a recall for many of its CPAP, BiPAP and ventilator machines because of concerns that users may inhale small particles of the foam used to dampen sound while the machines are in use. 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. You can find the list of products that are not affected as part of the corrective action. 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. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. How long will it take to address all affected devices? Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. 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. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. You are about to visit a Philips global content page. 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. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. 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. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP, System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series). The site is secure. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. Updating everyone on what they need to know and do, and to participate in the corrective action. 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. What is the advice for patients and customers? Click the link below to begin our registration process. Use of these devices may cause serious injuries or death. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. The .gov means its official.Federal government websites often end in .gov or .mil. We thank you for your patience as we work to restore your trust. An official website of the United States government, : This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. 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. For Spanish translation, press 2; Para espaol, oprima 2. . Has Philips received any reports of patient harm due to this issue? . However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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. 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. Philips Sleep and respiratory care. These printed instructions include a QR code you can scan, which will take you to an online instructional video. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Register your device on the Philips recall website or call 1-877-907-7508. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Select your country. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. All rights reserved. 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. The company has developed a comprehensive plan for this correction, and has already begun this process. For more information on the recall notification, 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 is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. No further products are affected by this issue. Click "Next". 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. 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. We thank you for your patience as we work to restore your trust. You are about to visit the Philips USA website. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. Are you still taking new orders for affected products? At the bottom of the page, select "I am a Patient/Device User/Caregiver". Are affected devices safe for 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. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. How will Philips address this issue? 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. We are in touch with relevant customers and patients. 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. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. Why did Philips issue the global recall notification in June 2021? BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. Koninklijke Philips N.V., 2004 - 2023. You are about to visit a Philips global content page. The new material will also replace the current sound abatement foam in future products. Please note that the information available at these links has not been separately verified by Philips Australia. Once you receive your replacement device, you will need to return your old device. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models 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. Consult your Instructions for Use for guidance on installation. 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. Where do I direct questions about my replacement device? The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. 3. 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. # x27 ; recall website or call 1-877-907-7508 in.gov or.mil and physicians, please click here Philips (. Spare parts are not affected as part of the recall referring to the Instructions, if there an! 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