BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON

    MDR report key: 492815 · Received October 16, 2003

    Report

    Report Number
    MW1029894
    Event Type
    Injury
    Date Received
    October 16, 2003
    Date of Event
    September 9, 2003
    Report Date
    October 16, 2003
    Manufacturer
    HAMILTON MEDICAL INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR SHUT ITSELF OFF WHILE ON THE PT. THE VENTILATOR WAS NOT DELIVERING BREATHS AND THE DISPLAY WENT BACK TO THE STARTUP SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON VENTILATOR CBK HAMILTON MEDICAL INC. GALILEO *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening