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. This Alert was related only to Trilogy 100 ventilators that were repaired. . Do affected units exhibit features that customers / users should watch out for? All rights reserved. At this time, affected devices are on manufacturing and ship hold. 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 Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Follow those instructions. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. This recall notification / field safety notice has not yet been classified by regulatory agencies. Are affected devices continuing to be manufactured and/or shipped? 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. 2. Membership & Community. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 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. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 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. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. For Spanish translation, press 2; Para espaol, oprima 2. . The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. 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. Do not stop or alter your prescribed ventilator therapy. 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. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Where do I direct questions about my replacement device? 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 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. Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Philips has been in full compliance with relevant standards upon product commercialization. Should affected devices be removed from service? This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . https://doi.org/10.1183/13993003.00551-2022, Continued patient outreach through mailing, call center, websites and direct contact with interest groups, Met the requirements in FDA's 518(a) order and continue to report progress, 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, 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, Lowprevalence of significant visible foam degradation, Evenwhen significant visible particulates are formed, likely to accumulate insidethe device, 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, 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. 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. 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; This Alert was related only to Trilogy 100 ventilators that were repaired. 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 Australia will work with your clinical care team to arrange a loan device, where required. Can Philips replace products under warranty or repair devices under warranty? A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. How will Philips address this issue? Can I trust the new foam? Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Philips Sleep and respiratory care. (0044) 20 8089 3822 Physicians and other medical care providers Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. 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. 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 We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). 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. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). How are you removing the old foam safely? 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 . People who receive breathing support from the affected Philips BiPAP (ventilator) machines. 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. The site is secure. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 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. 2. 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. 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 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). 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. Will existing patient devices that fail be replaced? A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. 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 . Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. Replace these devices with an unaffected device. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? Why did Philips issue the global recall notification in June 2021? Please note, the correction for Trilogy 100 is currently on hold. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please note that the information available at these links has not been separately verified by Philips Australia. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Is there a question we can answer for you? Philips is notifying regulatory agencies in the regions and countries where affected products are available. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. We are in touch with relevant customers and patients. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Click the link below to begin our registration process. 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. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Stopping treatment suddenly could have an immediate and detrimental effect on patient health. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. You can register here. 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. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. 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. 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. 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 Philips certain that this issue is limited to the listed devices? 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. 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. No further products are affected by this issue. Philips may work with new patients to provide potential alternate devices. Have regulatory authorities classified the severity of the recall? In the event of exposure to chemical emissions: 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. Register your device at the Phillips Respironics website (link below). Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. * Voluntary recall notification in the US/field safety notice for the rest of the world. Overview. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. . After registration, we will notify you with additonal information as it becomes available. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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. You are about to visit a Philips global content page. See all support information For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. 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. 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. If your physician determines that you must continue using this device. This factor does not refer to heat and humidity generated by the device for patient use. 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. The letter offered the following recommendations. We thank you for your patience as we work to restore your trust. 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. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 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. The plastic may also cause the machine to fail and stop working suddenly during use. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. How did this happen, and what is Philips doing to ensure it will not happen again? [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Don't have one? 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. 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. Selected products Are you still taking new orders for affected products? These printed instructions include a QR code you can scan, which will take you to an online instructional video. Patient safety is our top priority, and we are committed to supporting our . Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). As a first step, if your device is affected, please start theregistration process here. Only machines with serial numbers identified in the companys communications are affected by this recall. Contact your clinical care team to determine if a loan device is required. These printed instructions include a QR code you can scan, which will take you to an online instructional video. 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 4. What is meant by "high heat and humidity" being one of the causes of this issue? Please note, the correction for Trilogy 100 is currently on hold. 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. Information about the device for patient use compliance with medical device regulations, we will notify with! Critical issues with your clinical care team to determine if a recent call, letter email... 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