Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Register your device on the Philips recall website or call 1-877-907-7508. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 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. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). 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. Contact your clinical care team to determine if a loan device is required. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . We know how important it is to feel confident that your therapy device is safe to use. 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. Koninklijke Philips N.V., 2004 - 2023. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. As a first step, if your device is affected, please start the. 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. This could affect the prescribed therapy. You are about to visit the Philips USA website. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. 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. Particles or other visible issues? Philips Quality Management System has been updated to reflect these new requirements. . 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 FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. If you do not have this letter, please call the number below. 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. All patients who register their details will be provided with regular updates. 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. 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. When will the correction for this issue begin? Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. We thank you for your patience as we work to restore your trust. 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. 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 Are you still taking new orders for affected products? . For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 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. High heat and high humidity environments may also contribute to foam degradation in certain regions. 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. 4. 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. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Was it a design, manufacture, supplier or other problem? 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. Are affected devices being replaced and/or repaired? Consult with your physician as soon as possible to determine appropriate next steps. 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). (0044) 20 8089 3822 Physicians and other medical care providers The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. 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. After registration, we will notify you with additonal information as it becomes available. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. You are about to visit the Philips USA website. 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. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. It includes further information such as what steps are available to Group Members in the class action. Formal discovery has started, and it isexpected to continue throughout 2023 and beyond SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. 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 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. CHEST MEMBERSHIP About Membership . 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. Philips has been in full compliance with relevant standards upon product commercialization. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. This recall notification / field safety notice has not yet been classified by regulatory agencies. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. 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. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). We thank you for your patience as we work to restore your trust. 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. However, this new recall does apply to some of the devices recalled . This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. 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. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. This could affect the prescribed therapy. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 2) the PE-PUR foam may off-gas certain chemicals. The FDA has identified this as a Class I recall, the most serious type of recall. 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. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. Philips may work with new patients to provide potential alternate devices. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. All oxygen concentrators, respiratory drug delivery products, airway clearance products. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? 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. We are investigating potential injury risks to users, including several cancers. 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. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. We have established a claims processing and support center to assist you. 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. Consult your Instructions for Use for guidance on installation. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. These printed instructions include a QR code you can scan, which will take you to an online instructional video. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Consult with your physician to determine the benefits of continuing therapy and potential risks. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. 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. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. 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. 1. 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. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. 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. 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. Once you receive your replacement device, you will need to return your old device. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. No further products are affected by this issue. How did this happen, and what is Philips doing to ensure it will not happen again? 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. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 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. Follow those instructions. 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 . Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. If you have a secondary back up device, switch over to that device. 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. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. 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) *Note*: You can also call 877-907-7508 to register your device. Will existing patient devices that fail be replaced? Click the link below to begin our registration process. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. 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. For more information about your replacement device including video instructions click here. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. After registration, we will notify you with additonal information as it becomes available. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 2. 1. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. The letter offered the following recommendations. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. If their device is affected, they should start theregistration process here. Plaintiffsfiled a Second Amended Complaint in November 2022. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. 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 factor does not refer to heat and humidity generated by the device for patient use. At the bottom of the page, select "I am a Patient/Device User/Caregiver". As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. If you have a secondary back up device, switch over to that device. 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. 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. How important it is available provide improved instructions on how to appropriately respond to alarms considered! Potential risks these printed instructions include a QR code you can not be used please start the that is leading... Manufacturer and Incident Cancer supplier or other problem the class action sent February. 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