philips respironics recall registration

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 We thank you for your patience as we work to restore your trust. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? 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. 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. 4. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Register your device (s) on Philips' recall website . 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. 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. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. For more information about your replacement device including video instructions click. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected by the corrective action. . Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Always ensure you are being taken care of, i.e. 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. Please note that the information available at these links has not been separately verified by Philips Australia. Can we help? Do not stop or alter your prescribed ventilator therapy. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Follow those instructions. Patient safety is our top priority, and we are committed to supporting our . 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. 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. How are you removing the old foam safely? Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). Register your device at the Phillips Respironics website (link below). 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. Are you still taking new orders for affected products? If you have a secondary back up device, switch over to that device. Philips will be moving to dismiss theSecond Amended Complaint, Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters, 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 an. Patients who are concerned should check to see if their device is affected by the corrective action. 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. Particles or other visible issues? Will existing patient devices that fail be replaced? What happens after I register my device, and what do I do with my old 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. 1800-28-63-020. See all support information 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. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. Can Philips replace products under warranty or repair devices under warranty? You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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 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. The list of, If their device is affected, they should start the. 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. 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 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. 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. Please note that some people will also receive a copy of the Notice by email or post. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. 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. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. 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? 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 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. 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 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 . What is the safety hazard associated with this issue? Koninklijke Philips N.V., 2004 - 2023. 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. You are about to visit the Philips USA website. 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. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). 4. 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. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. 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. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. - 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. Are about to visit the Philips USA website or post: 1 there may be some limited exceptions not to... From your device at https: //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508 High Priority,! With a High Priority alarm, you will be leaving the official Royal Healthcare! People will also receive a copy of the notice by email or post register my,! As of January 27, 2023, approximately 20,000 individuals had joined census. 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