Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. All oxygen concentrators, respiratory drug delivery products, airway clearance products. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? The potential risks associated with this recall include: If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death. 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. 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. kidneys and liver) and toxic carcinogenic affects. Talk with health care providers to decide if your care and treatment should change as a result of this recall. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. CHEST Issues Joint Statement in Response to Philips Device Recall . On June 14, Philips issued a recall for many of its CPAP, BiPAP and ventilator machines because of concerns that users may inhale small particles of the foam used to dampen sound while the machines are in use. Has Philips received any reports of patient harm due to this issue? Philips Australia will work with your clinical care team to arrange a loan device, where required. 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. 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. 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 (International markets) / voluntary recall notification (U.S. only). Selected products 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). The .gov means its official.Federal government websites often end in .gov or .mil. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. 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. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. 1. 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. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. You can find the list of products that are not affected as part of the corrective actionhere. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. No further products are affected by this issue. The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. The new material will also replace the current sound abatement foam in future products. This could affect the prescribed therapy. 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. The contacts included Durable Medical Equipment (DME) suppliers. For Spanish translation, press 2; Para espaol, oprima 2. . 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Contact your clinical care team to determine if a loan device is required. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air The return shipment for your old device is pre-paid so there is no charge to you. Register your device at the Phillips Respironics website (link below). Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. An official website of the United States government, : Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. High heat and high humidity environments may also contribute to foam degradation in certain regions. Koninklijke Philips N.V., 2004 - 2023. . Philips CPAPs cannot be replaced during ship hold. Are affected devices continuing to be manufactured and/or shipped? 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. Once you receive your replacement device, you will need to return your old device. 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. 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. 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. Affected devices may be repaired under warranty. Please read the Notice carefully. Additional Resources: Medical Device Recall. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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. Will existing patient devices that fail be replaced? You are about to visit the Philips USA website. 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. We know how important it is to feel confident that your therapy device is safe to use. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. For more information on the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand, as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this correction, do not try to remove the foam from your device. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . 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. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. Are there any steps that customers, patients, and/or users should take regarding this issue? We are in touch with relevant customers and patients. Is there any possibility others are affected? Call us at +1-877-907-7508 to add your email. 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. 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 . Select country / language; Breathe easier, sleep more naturally Cookie Preferences . You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. However, this new recall does apply to some of the devices recalled in June 2021. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Membership. The criminal and civil investigation is being conducted by the DOJs Consumer Protection Branch and Civil Fraud Section and the US Attorneys Office for the Eastern District of Pennsylvania, Collectiveand individual civil complaints have been filed in various jurisdictionsglobally, including but not limited to the United States, Australia,Canada, Israel and Chile. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Click the link below to begin our registration process. If you do not have this letter, please call the number below. How it works. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Register your device (s) on Philips' recall website . Membership & Community. 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. 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. Should affected devices be removed from service? Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Select your country. 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). Follow those instructions. 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. As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. Images may vary. Plaintiffsfiled a Second Amended Complaint in November 2022. Always ensure you are being taken care of, i.e. 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. 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. 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. Is this a recall? 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. To identify affected products, sleep more naturally Cookie Preferences are affected devices on the recall (! 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