In those regions where Philips provides both patient care and devices, will new patients be set up with devices? 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 ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. Create account Create an account 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. How are you removing the old foam safely? Where do I direct questions about my replacement device? 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. 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. You are about to visit a Philips global content page. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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. Talk with health care providers to decide if your care and treatment should change as a result of this recall. We thank you for your patience as we work to restore your trust. Philips Quality Management System has been updated to reflect these new requirements. Click the link below to begin our registration process. 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. You are about to visit the Philips USA website. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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; What happens after I register my device, and what do I do with my old device? Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Plaintiffsfiled a Second Amended Complaint in November 2022. 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. The list ofaffected devices can be found here. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 1800-28-63-020. After registration, we will notify you with additonal information as it becomes available. 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) 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. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 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. 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. 2) the PE-PUR foam may off-gas certain chemicals. 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. 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. All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. 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. 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. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, was corrected or replaced through the June 2021 recall, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, report adverse reactions or quality problems, Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+. For more information on the recall notification for customers, users and physicians, please click here. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. This Alert was related only to Trilogy 100 ventilators that were repaired. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. For any other matters not directly related to Investor Relations, please visit our company contactspage. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. 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. 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 Sleep and respiratory care. 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. The relevant subsidiaries are cooperating with the agency. Please note that the information available at these links has not been separately verified by Philips Australia. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. 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. Consult with your physician to determine the benefits of continuing therapy and potential risks. Patients who are concerned should check to see if their device is affected by the corrective action. The FDA has identified this as a Class I recall, the most serious type of recall. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. Call us at +1-877-907-7508 to add your email. Koninklijke Philips N.V., 2004 - 2023. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. The recall includes many mechanical ventilator . Are there any steps that customers, patients, and/or users should take regarding this issue? 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. 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. The relevant subsidiaries are cooperating with the agency. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. Use of these devices may cause serious injuries or death. 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. An official website of the United States government, : We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? However, this new recall does apply to some of the devices recalled . We thank you for your patience as we work to restore your trust. In the event of exposure to degraded foam: 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. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Philips Sleep and respiratory care. 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 . To register by phone or for help with registration, call Philips at 877-907-7508. 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. ~90%production and 80% shipment of recall units, Encouraging test results for DS1platform (within safety norms), 483remediation and clarity on proposed Consent Decree, Driving patient engagement and registrations with dedicated registration system and infrastructure Continued patient outreach through mailing, call center, websites and direct contact with interest groups Comprehensive DME outreach Met the requirements in FDA's 518(a) order and continue to report progress Ongoing engagement with regulators to optimize the recall efforts Sharing progress on testing program to ensure patients and physicians fully informed, The task at hand Around 5.5M devices expected to berepaired or replaced Equivalent to over 5x previous annualproduction volume >1 thousand new product configurationsreleased globally Partnering with DMEs for patientdelivery, Progress to date Quadrupledproduction capacity compared to pre-recall >1,000people cross functional team engaged Dependencyon supply of materials and global logistics capacity ~90% production and 80% shipment of recall units in 2022, VOCtesting Emissions within ISO limits(devices not exposed to ozone) Visualinspection and assessment of the foam in used devices Lowprevalence of significant visible foam degradation Evenwhen significant visible particulates are formed, likely to accumulate insidethe device ParticulateMatter testing Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits Bioassayevaluation, chemical characterization and toxicological risk assessment Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Emissions within ISO limits(devices not exposed to ozone), Visualinspection and assessment of the foam in used devices, Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits, Bioassayevaluation, chemical characterization and toxicological risk assessment, Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Finalizetoxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in DreamStation1 devices Expected in Q2 2023 Completetesting for SystemOne(~26% of registered devices) and DreamStationGo (~1%), which contain the exact same foam as the DreamStation1 devices Expected in Q2 2023 CompleteVOC and PM testing, as well as chemical evaluation and toxicologicalassessments for Trilogy 100/200 (~3%) and OmniLab(~2%), where a different PE-PUR foam is used Expected in Q3 2023 Ongoingengagement with FDA and other competent authorities, There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click here for more details Two of the studies[1] [2]showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. Share our step-by-step walkthrough of the corrective action we are providing agencies with information... ) the PE-PUR foam may off-gas certain chemicals further information regarding warranty replacement procedures during this issue that credentials... 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