Register your device on the Philips recall website or call 1-877-907-7508. 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. Call us at +1-877-907-7508 to add your email. How will Philips address this issue? As of January 27, 2023,approximately 20,000 individuals had joined the census registry. High heat and high humidity environments may also contribute to foam degradation in certain regions. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. 2. Click the link below to begin our registration process. 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. 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. 2. 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. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance The relevant subsidiaries are cooperating with the agency. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. Philips Australia will work with your clinical care team to arrange a loan device, where required. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 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. That you are properly ventilated prior to referring to the instructions, IF THERE IS AN EMERGENCY, YOU MUST CALL 000. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. We are in touch with relevant customers and patients. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. The plastic may also cause the machine to fail and stop working suddenly during use. 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. 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. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. We know how important it is to feel confident that your therapy device is safe to use. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Plaintiffsfiled a Second Amended Complaint in November 2022. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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. Don't have one? At the bottom of the page, select "I am a Patient/Device User/Caregiver". 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. Plaintiffsfiled a Second Amended Complaint in November 2022. 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. As a first step, if your device is affected, please start the. Philips CPAPs cannot be replaced during ship hold. The list ofaffected devices can be found here. The application for discontinuance will be heard by the Federal Court on 3 April 2023. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Will existing patient devices that fail be replaced? As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Always ensure you are being taken care of, i.e. We thank you for your patience as we work to restore your trust. This factor does not refer to heat and humidity generated by the device for patient use. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Are there any steps that customers, patients, and/or users should take regarding this issue? Patient safety is our top priority, and we are committed to supporting our . Please note, the correction for Trilogy 100 is currently on hold. At this time, affected devices are on manufacturing and ship hold. Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. As a first step, if your device is affected, please start theregistration process here. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. Register your device (s) on Philips' recall website . Philips has been in full compliance with relevant standards upon product commercialization. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. 1. 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). Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. On June 14th, 2021, Philips Respironics released a safety communication statement that they will be issuing a device recall for almost all of their machines sold from 2009 to the present day. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). When will the correction for this issue begin? Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). The site is secure. 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. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. Koninklijke Philips N.V., 2004 - 2023. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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. 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. Philips Quality Management System has been updated to reflect these new requirements. Doing this could affect the prescribed therapy. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. 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. 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. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. 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. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Contact your clinical care team to determine if a loan device is required. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. We are in touch with relevant customers and patients. 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. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). At this time, Philips is unable to set up new patients on affected devices. The letter offered the following recommendations. What is the safety hazard associated with this issue? In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. We thank you for your patience as we work to restore your trust. The return shipment for your old device is pre-paid so there is no charge to you. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. 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. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Affected devices may be repaired under warranty. 2) the PE-PUR foam may off-gas certain chemicals. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. 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. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series). CHEST Issues Joint Statement in Response to Philips Device Recall . How are you removing the old foam safely? 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. We have established a claims processing and support center to assist you. All rights reserved. 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. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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 . Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. Before sharing sensitive information, make sure you're on a federal government site. 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