BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIRAFFE INCUBATOR

    MDR report key: 535264 · Received July 21, 2004

    Report

    Report Number
    1121732-2004-00006
    Event Type
    Other
    Date Received
    July 21, 2004
    Date of Event
    June 15, 2004
    Report Date
    July 19, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT SUDDENLY BEGAN DESCENDING TO THE LOWEST LEVEL IMMEDIATELY FOLLOWING A POWER OUTAGE. WHILE THE PT WAS IN THE INCUBATOR, THE UNIT CAUGHT ON A METAL PIECE WHICH WAS PROTRUDING FROM AN ADJACENT WALL AND BEGAN TO TIP TO THE SIDE. NURSES CAUGHT THE INCUBATOR AND HELD IT UP TO PREVENT IT FROM FALLING OVER UNTIL POWER WAS RESTORED AND THE NURSES WERE ABLE TO RE-ELEVATE THE BED TO A LEVEL THAT WOULD ALLOW IT TO BE FREE FROM THE METAL BRACKET ON THE WALL AND REMAIN UPRIGHT. THE PT WAS MOVED TO A DIFFERENT INCUBATOR. NO PT OR STAFF INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE INCUBATOR INFANT THERMOREGULATION FMZ OHMEDA MEDICAL * HDHF54162

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other