BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 669886 · Received January 25, 2006

    Report

    Report Number
    1121732-2006-00004
    Event Type
    Malfunction
    Date Received
    January 25, 2006
    Date of Event
    January 4, 2006
    Report Date
    January 25, 2006
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT WAS SET CONTINUALLY TO 39.1 C WITHOUT A REDUCTION IN HEAT. THERE WAS NO REPORTED PT INJURY. OHMEDA MEDICAL'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE OMNIBED INFANT THERMOREGULATION FMT OHMEDA MEDICAL GIRAFFE OMNIBED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO