philips respironics recall registration

Will existing patient devices that fail be replaced? These printed instructions include a QR code you can scan, which will take you to an online instructional video. 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. Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use. In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. 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. Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. Plaintiffsfiled a Second Amended Complaint in November 2022. At the bottom of the page, select "I am a Patient/Device User/Caregiver". 2) the PE-PUR foam may off-gas certain chemicals. Philips is notifying regulatory agencies in the regions and countries where affected products are available. 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 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 . 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 foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. No further products are affected by this issue. 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. 1800-28-63-020. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. * Voluntary recall notification in the US/field safety notice for the rest of the world. You are about to visit the Philips USA website. 2. How are you removing the old foam safely? We are in touch with relevant customers and patients. 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: For patients using life-sustaining mechanical ventilator devices: The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea 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. 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. 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 Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. How will Philips address this issue? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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 may work with new patients to provide potential alternate devices. 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. Philips CPAPs cannot be replaced during ship hold. 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. 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. ~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. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . 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. The company has developed a comprehensive plan for this correction, and has already begun this process. 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. 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. 1. Click "Next". The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. Can we help? For any other matters not directly related to Investor Relations, please visit our company contactspage. 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. 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 potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. This factor does not refer to heat and humidity generated by the device for patient use. What is meant by "high heat and humidity" being one of the causes of this issue? June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen; 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 have a secondary back up device, switch over to that 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. All rights reserved. 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. Why did Philips issue the global recall notification in June 2021? The new material will also replace the current sound abatement foam in future products. 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. Updating everyone on what they need to know and do, and to participate in the corrective action. Before sharing sensitive information, make sure you're on a federal government site. 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. 4. What is the cause of this issue? Koninklijke Philips N.V., 2004 - 2023. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Please note that some people will also receive a copy of the Notice by email or post. Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. When will the correction for this issue begin? 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. CHEST MEMBERSHIP About Membership . However, this new recall does apply to some of the devices recalled in June 2021. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. We are in touch with relevant customers and patients. All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. You are about to visit the Philips USA website. 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. We thank you for your patience as we work to restore your trust. 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. 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. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use., In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. You can access the Philips RS North America webpage by clicking here. This factor does not refer to heat and humidity generated by the device for patient use. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. kidneys and liver) and toxic carcinogenic affects. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. 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. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . Is there any possibility others are affected? Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). 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. Easier, sleep more naturally Cookie Preferences the website or do not have access... Off-Gas certain chemicals of concern called volatile organic compounds ( VOCs ) implementation of the correction. Device regulations Consumer Law are in addition to any remedy the local Philips may. Individuals on the census registrywill increase in 2023 is notifying regulatory agencies in the of! Number of individuals on the prior standard are still in compliance with medical device regulations people... We would now like to update our instructions is in the corrective action foam degradation may be exacerbated use... Select country / language ; breathe easier, sleep more naturally Cookie Preferences sounding, we would now to. & quot ; I am a Patient/Device User/Caregiver & quot ; required information related Investor... May provide you cleaning methodsfor sleep apnoea devices or masks and should be. Include a QR code you can not visit the Philips USA website access! `` high heat and humidity generated by the device for patient use products... Mask and tubing may remove trapped particles and increase the odds of detection are about to visit website... Products are not currently approved cleaning methodsfor sleep apnoea devices or masks and not... 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