BEUDAMED
    FDA Recall Open, Classified

    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

    Recall: Z-1956-2021 · Initiated June 14, 2021

    Recall

    Recall Number
    Z-1956-2021
    Event Number
    88071
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 14, 2021
    Posted
    July 15, 2021
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

    Reason

    The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

    Action

    Urgent Medical Device Recall letters were sent to customers starting 6/14/21. 1. Do not stop or alter your prescribed therapy until you have talked to your physician. Your physician may evaluate if the benefit outweighs the risks. 2. If your physician determines that you must continue using this device, use an inline bacterial filter. Your Instructions for Use has guidance on installation. 3. Register your device on www.philips.com/src-update or call 1-877-907-7508. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. 1. Do not stop or change ventilator use until you have talked to your health care provider. If patients requiring a ventilator for life-sustaining therapy have no alternate, or therapy disruption is unacceptable, the HCP may determine if the benefit of continued use of these ventilator devices outweighs the potential risks identified in the recall letter. 2. Talk to your HCP about using an inline bacterial filter to help filter out foam particles. Instructions for Use has guidance on installation. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and evaluation is ongoing. Filters will not reduce exposure to chemicals from the PE-PUR foam. Filters may increase air flow resistance and affect ventilator performance. Monitor for accumulation of foam debris in the filter or resistance-related problems in the breathing circuit after filter placement. 3. Report any problems with a device through the FDA MedWatch Voluntary Reporting Form. 4. Register your device on the recall website www.philips.com/src-update with your device Serial Number, or call 1-877-907-7508. Devices should be serviced only by qualified technicians. There are no user serviceable parts. Attempts to remove the sound abatement foam may render the device permanently inoperative. Devices damaged due to foam removal attempts will not be able to be remediated.

    Distribution

    Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.

    Quantity

    255810