BEUDAMED
    FDA Recall Open, Classified

    Puritan Bennett 980 Series Ventilator

    Recall: Z-0966-2022 · Initiated March 25, 2022

    Recall

    Recall Number
    Z-0966-2022
    Event Number
    89820
    Firm
    Medtronic formerly Covidien Michael Collins Road, Mervue Ind. Park Galway Ireland
    FEI Number
    3002807850
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2022
    Posted
    April 25, 2022

    Description

    Puritan Bennett 980 Series Ventilator

    Reason

    The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.

    Action

    The firm notified consignees starting on March 25, 2022 via customer letter. Customers were informed of the issue and advised to institute workflow modifications to ensure visibility of the GUI visual alarm banner to ensure awareness of an active alarm condition in the absence of a functioning audible alarm and/or omni-directional LED visual alarm. If the audible alarm or omni-directional LED alarm fail, the clinical team should transfer the patient to another form of ventilation. The firm will correct the issue in a future software update. For questions contact your Medtronic representative or Technical Service at 1-800-255-6774 The firm sent additional correction notices to consignees that received affected devices before the software correction was distributed.

    Distribution

    US Nationwide - Worldwide .Distribution

    Quantity

    18,508 OUS; 18,412 US