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. 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. (, 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. If you have a secondary back up device, switch over to that device. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. 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. What is the safety hazard associated with this issue? If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). What is meant by "high heat and humidity" being one of the causes of this issue? Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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 patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . For any other matters not directly related to Investor Relations, please visit our company contactspage. The site is secure. This could affect the prescribed therapy. 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. 2. 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. Are you still taking new orders for affected products? The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. UPDATENovember 6, 2022: After further review of medical device reports, the FDA has revised the list of potential risks associated with this recall in the section, Reason for Recall. 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. You are about to visit the Philips USA website. Theremediation of this field safety notice is underway and has started for the following devices: Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. 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. Are affected devices safe for use? Do affected units exhibit features that customers / users should watch out for? 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. This factor does not refer to heat and humidity generated by the device for patient use. Please note, the correction for Trilogy 100 is currently on hold. Philips Quality Management System has been updated to reflect these new requirements. For more information about your replacement device including video instructions click. Can Philips replace products under warranty or repair devices under warranty? 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) 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. The application for discontinuance will be heard by the Federal Court on 3 April 2023. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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. Philips Sleep and respiratory care. For more information on the recall notification for customers, users and physicians, please click here. How will Philips address this issue? Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. 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. The products were designed according to, and in compliance with, appropriate standards upon release. 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. 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. If you have not done so already, please click here to begin the device registration process. The recall includes many mechanical ventilator . 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. 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. Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device. Medical Device recall notification (U.S. only) / field safety notice (International Markets). [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. Always ensure you are being taken care of, i.e. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. Koninklijke Philips N.V., 2004 - 2023. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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. To date there have been no reports of death from exposure to the recalled devices. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. The new material will also replace the current sound abatement foam in future products. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? Register your product and enjoy the benefits. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. 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. What devices have you already begun to repair/replace? What is the cause of this issue? 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. 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. Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Additionally, the device Instructions for Use provide product identification information to assist with this activity. Consult with your physician as soon as possible to determine appropriate next steps. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. kidneys and liver) and toxic carcinogenic affects. 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. Once you receive your replacement device, you will need to return your old device. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. The FDA has identified this as a Class I recall, the most serious type of recall. 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. These communications will be sent throughout February 2023 with all notices scheduled to be sent by 27 February 2023. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. We thank you for your patience as we work to restore your trust. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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). A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Philips CPAPs cannot be replaced during ship hold. Follow those instructions. If your physician determines that you must continue using this device, use an inline bacterial filter. 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. You can register here. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Testing is ongoing and you can obtain further information about the. 3. Where do I direct questions about my replacement device? Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Always ensure you are being taken care of, i.e. Can I trust the new foam? 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 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. 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. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. This factor does not refer to heat and humidity generated by the device for patient use. 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. 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. 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. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. The company has developed a comprehensive plan for this correction, and has already begun this process. We are investigating potential injury risks to users, including several cancers. 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. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. If your physician determines that you must continue using this device. How it works. 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 issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 1. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. *Note*: You can also call 877-907-7508 to register your device. CHEST MEMBERSHIP About Membership . 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