Field Safety Notice (Outside Of U.S.) Medical Device .
7/8/2021Sleep and respiratory care update PhilipsClick here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices › Medical Device recall notification (U.S. only) /field safety notice (Outside of U.S.)Philips RespironicsThere is nothing we take more seriously than providing patients withhigh quality products that are safe and reliable. If an issue arises, weare proactive in communicating and addressing it as we worktirelessly towards a resolution.On April 26, 2021, Philips provided an important update regarding proactive efforts to address identifiedissues with a component in certain products of our Sleep & Respiratory Care portfolio.At that time, out of an abundance of caution and based on available information, Philips advised of potentialhealth risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure(CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The companyalso indicated that analysis of potential health risks was ongoing, and that further information would beprovided when available.As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the companyissued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.The notification informs customers and users of potential impacts on patient health and clinical use related tothis issue. Possible health risks include exposure to degraded sound abatement foam, for example caused byunapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.High heat and high humidity environments may also contribute to foam degradation in certain regions.To date, Philips has received a limited number of reports of possible patient impact due to foam degradation,and no reports to date regarding patient impact related to chemical emissions. The company continues tomonitor reports of potential safety issues as required by medical device regulations and laws in the marketsin which we leep/communications/src-update1/11
7/8/2021Sleep and respiratory care update PhilipsThe notification advises patients and customers to take the followingactions: For patients using BiLevel PAP and CPAP devices:Discontinue use of affected units and consult with physicians to determine thebenefits of continuing therapy and potential risks. For patients using life-sustaining mechanical ventilator devices:DO NOT discontinue or alter prescribed therapy, without consulting physicians todetermine appropriate next steps.Philips is recommending that customers and patients do not use ozone-relatedcleaning products.Additionally, Philips is reminding customers and patients to review the age of theirBiLevel PAP and CPAP devices, as they are recommended to be replaced after fiveyears of use.We are treating this matter with the highest possible seriousness, and are working to address this issue asefficiently and thoroughly as possible.The company has developed a comprehensive plan to replace the current sound abatement foam with a newmaterial that is not affected by this issue, and has already begun this process.For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well asinstructions for customers, users and physicians, affected parties may contact their local Philipsrepresentative or visit www.philips.com/SRC-update. What you need to do What devices are affected Questions and eep/communications/src-update2/11
7/8/2021Sleep and respiratory care update PhilipsHelpQuestions? Call877-907-7508 Toll-free in the USAOutside the USA call(0044) 20 8089 3822 Begin registration processWhat you need to doPhilips is committed to rectfying this issue through a robust and comprehensive repair andreplacement program. We have established a claims processing and support center toassist you.Durable Medical EquipmentProviders, Distributors, or MedicalInstitutions Click the link below to begin our registration process. If you arein the United States, you will receive a letter by June 23, 2021from Philips about this issue that contains log-in credentials forthe registration website. If you are located outside of the UnitedStates, you will receive the letter shortly thereafter. If you do notreceive this letter, please call the number below.After registration, we will notify you with additonal informationas it becomes /sleep/communications/src-update3/11
7/8/2021Sleep and respiratory care update Philips Begin registration process 877-907-7508Downloadable resourcesPatients, Users, or Caregivers Philips has established a registration process that allows Patients,Users, or Caregivers to look up their device serial number andbegin a claim if their unit is affected.At this time, this process is only available for Patients, Users, orCaregivers in the USA and Canada. More countries will be addedshortly. Begin registration process 877-907-7508Physicians and other medicalcare providers Click the link below for additional clinical details on the issue andother information to help you advise your patients who havebeen impacted. Learn /communications/src-update4/11
7/8/2021Sleep and respiratory care update PhilipsWhat devices are affected by the recallnotification / field safety notice?The recall notification (U.S. only) / field safety notice (Outside of U.S.) provides customers with informationon how to identify affected products.Additionally, the device Instructions for Use provide product identification information to assist with thisactivity.Products listed in this notification include:CPAP and BiLevel PAP DevicesAll Affected Devices Manufactured Before 26 April 2021, All Device SerialNumbersContinuous Ventilator, Minimum Ventilatory Support, Facility UseE30(Emergency Use Authorization)Continuous Ventilator, Non-life /sleep/communications/src-update5/11
7/8/2021Sleep and respiratory care update PhilipsDreamStationDreamStationASVST, AVAPSSystemOneC SeriesASV4ASV, S/T, AVAPSOmniLab Advanced PlusIn-Lab Titration DeviceNon-continuous /sleep/communications/src-update6/11
7/8/2021Sleep and respiratory care update PhilipsSystemOneDreamStation(Q series)CPAP, Auto CPAP, BiPAPDreamStation GODorma 400, 500CPAP, APAPCPAPREMStar SE AutoCPAPMechanical VentilatorsAll Affected Devices Manufactured Before 26 April 2021, All Device e/e/sleep/communications/src-update7/11
7/8/2021Sleep and respiratory care update PhilipsContinuous VentilatorTrilogy 100Trilogy 200VentilatorVentilatorGarbin Plus, Aeris, LifeVentVentilatorContinuous Ventilator, Minimum Ventilatory Support, Facility UseA-Series BiPAP Hybrid A30A-Series BiPAP V30 Auto(not marketed in e/e/sleep/communications/src-update8/11
7/8/2021Sleep and respiratory care update PhilipsContinuous Ventilator, Non-life SupportingA-Series BiPAP A40A-Series BiPAP A30(not marketed in US)(not marketed in US)What products are not affected and why?Products that are not affected may have different sound abatement foam materials, asnew materials and technologies are available over time. Also, sound abatement foam inunaffected devices may be placed in a different location due to device design.Products not affected by this recall notification (U.S. only) / field safetynotice (International Markets) include: Trilogy Evo Trilogy Evo OBM Trilogy EV300 Trilogy 202 A-Series Pro and EFL M-Series DreamStation 2 Omnilab (original based on Harmony 2) Dorma 100, Dorma 200, & REMStar SE V60 /sleep/communications/src-update9/11
7/8/2021Sleep and respiratory care update Philips V60 Plus Ventilator V680 Ventilator All oxygen concentrators, respiratory drug delivery products, airway clearanceproducts.Questions and answersAre affected devices safe for use? Should affected devices be removed from service? The recall notification (U.S. only) / field safety notice (Outside of U.S.) advises patients andcustomers 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 ofcontinuing therapy and potential risks. For patients using life-sustaining mechanical ventilator devices:DO NOT discontinue or alter prescribed therapy, without consulting physicians to determineappropriate next steps.Philips is recommending that customers and patients do not use ozone-related cleaning products.Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP andCPAP devices, as they are recommended to be replaced after five years of use.What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due tothis issue? When will the correction for this issue begin? How long will it take to address all affected devices? Is this a recall? Have regulatory authorities classified the severity of the recall? How will Philips address this issue? Are affected devices being replaced and/or repaired? Are customers entitled to warranty replacement, repair, service or other mitigations?Are affected devices continuing to be manufactured and/or shipped?Are there any steps that customers, patients, users and/or clinicians should take regarding this issue?What is the cause of this issue? Was it a design, manufacture, supplier or other problem?How did this happen, and what is Philips doing to ensure it will not happen again?What is meant by "high heat and humidity" being one of the causes of this ep/communications/src-update 10/11
7/8/2021Sleep and respiratory care update PhilipsDo affected units exhibit features that customers / users should watch out for? Particles or other visibleissues?Can Philips replace products under warranty or repair devices under warranty?In those regions where Philips provides both patient care and devices, will new patients be set up withdevices? Will existing patient devices that fail be replaced? Is Philips certain that this issue is limited to the listed devices? Is there any possibility others are affected? Koninklijke Philips N.V., 2004 - 2021. All rights sleep/communications/src-update11/11
new materials and technologies ar e avai lable over time. Also, sound abatement f oam in. unaffected devices ma y be placed in a di fferent location due to device design. Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include: Tri logy Evo Tri lo
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Date URGENT FIELD SAFETY NOTICE: RA2012-035C Dear Customer Description: Neptune Waste Management System. Catalog # 0702-001-000, 0702-002-000, 0700-001-000, 0700-002-000, 0700-003-000, 0700-007-000 Lot # All devices/serial numbers In May 2012 Stryker Instruments initiated a Product Field Action to inform users that the IFU for the Neptune 2 devices had been
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