BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED WITH EXAM LIGHT

    MDR report key: 2433130 · Received January 25, 2012

    Report

    Report Number
    MW5024015
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    GE MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXAM LIGHT ACCESSORY TO GE MEDICAL GIRAFFE OMNIBED CAN MELT IF LEFT UNDER RADIANT WARMER HEATING ELEMENT. ALTHOUGH A WARNING LABEL ON THE EXAM LIGHT STATES THAT THE LIGHT SHOULD BE KEPT AWAY FROM THE OMNI BED HEATING ELEMENT, IT IS VERY EAST FOR STAFF TO LEAVE IT IN THIS POSITION. THE DESIGN IS VERY SUSCEPTIBLE TO HUMAN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE OMNIBED WITH EXAM LIGHT GIRAFFE OMNIBED WITH EXAM LIGHT FMZ GE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1