Are affected devices safe for use? As of January 27, 2023,approximately 20,000 individuals had joined the census registry. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). 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. Process Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers The FDA acknowledges that the submission of anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. Philips may work with new patients to provide potential alternate devices. Call us at +1-877-907-7508 to add your email. 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. 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. At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Once you receive your replacement device, you will need to return your old device. Do not stop or alter your prescribed ventilator therapy. Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS 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. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. Are spare parts currently part of the ship hold? This Alert was related only to Trilogy 100 ventilators that were repaired. 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. The return shipment for your old device is pre-paid so there is no charge to you. All patients who register their details will be provided with regular updates. 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. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. Affected devices may be repaired under warranty. If you have not done so already, please click here to begin the device registration process. Affected devices may be repaired under warranty. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? All oxygen concentrators, respiratory drug delivery products, airway clearance products. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. All rights reserved. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. The relevant subsidiaries are cooperating with the agency. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. 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. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. What devices have you already begun to repair/replace? For more information about your replacement device including video instructions click. 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. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. However, this new recall does apply to some of the devices recalled . Patients who are concerned should check to see if their device is affected by the corrective action. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. At the bottom of the page, select "I am a Patient/Device User/Caregiver". The list ofaffected devices can be found here. 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; Please note that the information available at these links has not been separately verified by Philips Australia. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. 4. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. You are about to visit a Philips global content page. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. This factor does not refer to heat and humidity generated by the device for patient use. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Patient safety is our top priority, and we are committed to supporting our . Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. 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. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Philips Australia will work with your clinical care team to arrange a loan device, where required. CHEST MEMBERSHIP About Membership . To register your product, you'll need to log into you're my Philips account. 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. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 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. Before sharing sensitive information, make sure you're on a federal government site. . An official website of the United States government, : We are in touch with relevant customers and patients. 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. 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. 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. 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. Should affected devices be removed from service? 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. How it works. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. 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. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). The FDA has identified this as a Class I recall, the most serious type of recall. 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. 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) 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . 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. - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. The relevant subsidiaries are cooperating with the agency. Register your device (s) on Philips' recall website . The plastic may also cause the machine to fail and stop working suddenly during use. The products were designed according to, and in compliance with, appropriate standards upon release. 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. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Doing this could affect the prescribed therapy. However, this new recall does apply to some of the devices recalled in June 2021. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Consult your Instructions for Use for guidance on installation. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. The new material will also replace the current sound abatement foam in future products. What is the safety hazard associated with this issue? How will Philips address this issue? Replace these devices with an unaffected device. 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 also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 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. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. 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. 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. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). Plaintiffsfiled a Second Amended Complaint in November 2022. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). 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. This recall notification / field safety notice has not yet been classified by regulatory agencies. Always ensure you are being taken care of, i.e. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. The contacts included Durable Medical Equipment (DME) suppliers. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. Testing is ongoing and you can obtain further information about the. Was it a design, manufacture, supplier or other problem? 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. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). 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. 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. 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. Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. (0044) 20 8089 3822 Physicians and other medical care providers 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. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. We thank you for your patience as we work to restore your trust. 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 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. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. You can register here. You are about to visit a Philips global content page. 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. `` Accessory Cleaning and Inspection instructions '' provided and if you have not done so already, contact! Physicians to determine appropriate next steps due to device design share next steps so you can register your,. Supporting our machine to fail and stop working suddenly during use click here to the! 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