BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 3120086 · Received May 15, 2013

    Report

    Report Number
    3120086
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    THE EXAM LIGHT ON THE GE HEALTHCARE, GIRAFFE OMNIBED INCUBATOR BROKE ON THE MOUNTING ARM NEAR THE PIVOT POINT WHEN THE LIGHT WAS ADJUSTED. THIS COULD HAVE RESULTED IN THE LIGHT FALLING ON THE BABY. OTHER LIGHTS ON THE OMNIBED INCUBATORS WERE INSPECTED AND 8 OTHER LIGHTS WERE FOUND TO BE CRACKED. THE DEFECTIVE LIGHTS WERE REMOVED FROM SERVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VIEWING THE BABY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214871 GIRAFFE OMNIBED INCUBATOR, NEONATAL FMZ GE HEALTHCARE, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *