BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE INCUBATOR

    MDR report key: 558921 · Received December 1, 2004

    Report

    Report Number
    558921
    Event Type
    Malfunction
    Date Received
    December 1, 2004
    Date of Event
    November 9, 2004
    Report Date
    November 22, 2004
    Manufacturer
    OHMEDA MEDICAL A DIVISION OF GE MEDICAL
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S IN AN ISOLETTE WITH VITAL SIGNS STABLE. THE ISOLETTE SOUNDED AN ALARM AND THE MESSAGE "SYSTEM MALFUNCTION" APPEARED. THE ISOLETTE WAS TURNED OFF AND STARTED AGAIN. TWENTY MINUTES LATER THE SAME THING HAPPENED AGAIN.FOLLOW UP REVEALS:NO ADVERSE PATIENT OUTCOME.UNIT FOUND TO HAVE ERROR 16 AND 23 CODES. TRACED FAILURE TO FAULTY SOLID START RELAY. RELAY WAS REPLACED AND UNIT TESTED TO SPECS. RETURNED UNIT TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE INCUBATOR INCUBATOR FMT OHMEDA MEDICAL A DIVISION OF GE MEDICAL GIRAFFE *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA NONE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE| NO OTHER THERAPIES| EVENT.