BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 520305 · Received March 26, 2004

    Report

    Report Number
    MW1031694
    Event Type
    Injury
    Date Received
    March 26, 2004
    Date of Event
    March 13, 2004
    Report Date
    March 26, 2004
    Manufacturer
    OHMEDA MEDICAL NOW GE MEDICAL SYSTEMS
    Product Code
    FMT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT IN GIRAFFE BED, VENTILATED; BED TO MAINTAIN 98.6 TEMPERATURE. BED CONTROL PANEL FAILED AND BED WAS PLACED ON MANUAL MODE. TEMPERATURE ATTEMPTED TO BE CONTROLLED FOR THE GIRAFFE UNIT. PT CONTINUED TO INCREASE IN BODY TEMPERATURE RISING TO 101.0 WITH TEMPERATURE PRODUCED BY BED UNCONTROLABLE. PT TAKEN OUT OF THE UNIT. DISCOVERED FROM CO TECH REP THAT A NEW REVISION WAS COMING OUT ON THE "RELAY CIRCUIT BOARD" THAT CONTROLS THE DIGITAL DISPLAYS. HOWEVER THEY WERE NOT AVAILABLE FOR THESE BEDS YET AS THEY WERE REPAIRING THE NEWER BEDS FIRST. CO PLANNING TO REPLACE ALL CIRCUIT BOARDS IN BOTH RPTR'S BEDS. SECOND BED HAS ALSO HAD INTERMITTENT CONTROL BOARD PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE OMNIBED NICU ISOLETTE FMT OHMEDA MEDICAL NOW GE MEDICAL SYSTEMS 6650-0032-901 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention