BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL, INC.

    MDR report key: 2069578 · Received April 20, 2011

    Report

    Report Number
    MW5020348
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    April 18, 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 STOPPED VENTILATING AND STARTED EMITTING A HIGH PITCHED ALARM. THERAPIST REPORTS THAT THE SCREEN WENT BLACK AND THEN ENTERED SELF TEST MODE. NO BUTTONS FUNCTION AND VENTILATOR COULD NOT BE RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON MEDICAL, INC. C-2 VENTILATOR CBK HAMILTON MEDICAL, INC. C-2 160002

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability