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. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. 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. Updating everyone on what they need to know and do, and to participate in the corrective action. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Distribution Dates: August 6, 2020, to September 1, 2021, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. 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. On June 14th, 2021, Philips Respironics released a safety communication statement that they will be issuing a device recall for almost all of their machines sold from 2009 to the present day. 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. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. 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. Philips has been in full compliance with relevant standards upon product commercialization. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. 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). Follow the steps for registering your device. All rights reserved. Use of these devices may cause serious injuries or death. If you have a secondary back up device, switch over to that device. 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 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. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). 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. 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 . You are about to visit a Philips global content page. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Philips CPAPs cannot be replaced during ship hold. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). * Voluntary recall notification in the US/field safety notice for the rest of the world. Only machines with serial numbers identified in the companys communications are affected by this recall. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. The affected products are identified in the tables below: A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), 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. Select your country. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 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. Click "Next". 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 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. 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. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Has Philips received any reports of patient harm due to this issue? Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). The letter offered the following recommendations. Royal Philips (NYSE: PHG) is promising a turnaround from its bottom-line woes, which began with one of the largest medical devices recalls in recent history. 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected by the corrective action. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration 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. 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. 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. 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. If their device is affected, they should start theregistration process here. All patients who register their details will be provided with regular updates. 4. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . 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. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. 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. 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). Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. This potentially deadly combination . 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. Overview. Always ensure you are being taken care of, i.e. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. 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. However, this new recall does apply to some of the devices recalled . For any other matters not directly related to Investor Relations, please visit our company contactspage. 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. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Images may vary. Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. The correction program is now in progress for the following devices: 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) DreamStation Go With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Follow those instructions. *Note*: You can also call 877-907-7508 to register your device. You can access the Philips RS North America webpage by clicking here. High heat and high humidity environments may also contribute to foam degradation in certain regions. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. 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. 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. 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. If you do not have this letter, please call the number below. Philips Australia will work with your clinical care team to arrange a loan device, where required. We thank you for your patience as we work to restore your trust. See all support information If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Patients who are concerned should check to see if their device is affected by the corrective action. 2. The relevant subsidiaries are cooperating with the agency. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 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 your device (s) on Philips' recall website . Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. 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. We have established a claims processing and support center to assist you. 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. Please note that some people will also receive a copy of the Notice by email or post. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider. 3. (0044) 20 8089 3822 Physicians and other medical care providers 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. We thank you for your patience as we work to restore your trust. The products were designed according to, and in compliance with, appropriate standards upon release. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. The .gov means its official.Federal government websites often end in .gov or .mil. 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. The plastic may also cause the machine to fail and stop working suddenly during use. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. This could affect the prescribed therapy. Do affected units exhibit features that customers / users should watch out for? Philips may work with new patients to provide potential alternate devices. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. ~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. 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. Membership & Community. 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. Replace these devices with an unaffected device. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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. 1. If you have a secondary back up device, switch over to that device. An official website of the United States government, : At this time, Philips is unable to set up new patients on affected devices. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 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. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. 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. The list of, If their device is affected, they should start the. 2. 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 recall notification / field safety notice has not yet been classified by regulatory agencies. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. Are customers entitled to warranty replacement, repair, service or other mitigations? Can we help? Click the link below to begin our registration process. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Call us at +1-877-907-7508 to add your email. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). 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. 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. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. 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