BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURITAN BENNETT

    MDR report key: 3874207 · Received June 11, 2014

    Report

    Report Number
    MW5036605
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING PM ROUNDING ON VENTILATORS THE RT DIRECTOR FOUND AN O2 SENSOR ALARM WITH "DISABLED" ON THE SCREEN, WHEN ENABLED, THE VENT CONTINUOUSLY ALARMED. VENT REMOVED FROM SERVICE. O2 SENSOR FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344411 PURITAN BENNETT VENTILATOR CBK COVIDIEN 760

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR