BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL, INC.

    MDR report key: 2037652 · Received March 28, 2011

    Report

    Report Number
    MW5020007
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR IN USE ON AN INTENSIVE CARE PT FAILED. DEVICE FAILURE ALARM SOUNDED. PT REMOVED FROM THE VENTILATOR AND WAS VENTILATED MANUALLY UNTIL A REPLACEMENT UNIT COULD BE SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON MEDICAL, INC. C-2 VENTILATOR CBK HAMILTON MEDICAL, INC. C2 2010

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| S