BEUDAMED
    FDA Adverse Event Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 3148766 · Received May 24, 2013

    Report

    Report Number
    3148766
    Date Received
    May 24, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GE HEALTHCARE, LLC.
    Product Code
    FMZ
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    GIRAFFE BED ALARMED FOR "FAN MALFUNCTION" HOWEVER, EVERYTHING APPEARED TO BE FUNCTIONING OKAY (APPROPRIATE HEAT OUTPUT AND BABY'S TEMP WAS FINE). BED TURNED OFF AND TURNED BACK ON. NEW ERROR "SYSTEM FAILURE 25" NOTED ON SCREEN AND BED WOULD NOT FUNCTION AT ALL.AFTER BIOMED INVESTIGATED, WE FOUND THE BEARINGS OF THE FAN MOTOR WERE DEFECTIVE. THIS IS THE 6TH ONE OF THESE BEDS THAT HAVE HAD THIS PROBLEM. WE REPLACED THE BEARINGS AND RETURNED TO SERVICE. WE ALSO CHECKED WITH STAFF THAT PERFORM THE CLEANING OF THE BEDS TO MAKE SURE THEY WERE NOT CAUSING LIQUID TO ENTER INTO THE FAN MOTOR BEARINGS. THEIR CLEANING METHOD IS FINE, NOT GETTING LIQUID INTO THE MOTOR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?WARMING THE NEONATE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230623 GIRAFFE OMNIBED WARMER, INFANT, RADIANT FMZ GE HEALTHCARE, LLC. 6650-0004-901 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES