BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL, INC.

    MDR report key: 2069589 · Received April 20, 2011

    Report

    Report Number
    MW5020349
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 20, 2011
    Manufacturer
    HAMILTON MEDICAL INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR ON PT ALARMED WITH ERROR MESSAGE STATION "WRONG BATTERY TYPE". THE VENTILATOR WAS ALARMING TO ITSELF AND RESETTING ITSELF WITHOUT USER INTERVENTION. VENT WAS REMOVED AND PLACED ON A TEST LUNG RESULTING IN VENTILATOR FAILURE APPROXIMATELY 4 HOURS AFTER BEING PLACED ON THE TEST PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON MEDICAL, INC. C-2 VENTILATOR CBK HAMILTON MEDICAL INC. C-2 160001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability