BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G.E. OMNIBED

    MDR report key: 3466134 · Received November 6, 2013

    Report

    Report Number
    MW5032643
    Event Type
    Injury
    Date Received
    November 6, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 30, 2013
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    G.E., GIRAFFE ISOLETTE WAS PRE-WARMED IN THE ISOLETTE MODE. ISOLETTE WAS OPENED TO RADIANT WARMER MODE AND PT PLACED IN BED. WHEN THE ISOLETTE WAS CLOSED THE ALARM READ AIR TEMP PROBE FAILURE. THE BED WAS TURNED OFF THEN BACK ON WITH NO RESOLUTION. DIAGNOSIS OR REASON FOR USE: EXTREME PREMATURITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571757 G.E. OMNIBED GIRAFFE OMNIBED FMZ GENERAL ELECTRIC HDGR 52792

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention