BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATEX/OHMEDA (GE) GIRAFFE OMNIBED ISOLETTE

    MDR report key: 13600749 · Received February 24, 2022

    Report

    Report Number
    MW5107705
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    December 29, 2021
    Report Date
    February 22, 2022
    Manufacturer
    DATEX/OHMEDA (GE) / DATEX-OHMEDA, INC.
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GIRAFFE OMNIBED BARCODE (B)(4) AND SERIAL NUMBER (B)(4); INCUBATOR. INFANT FLIPPED ARM INTO SIDE RAIL SPACE AS IT WAS CLOSED, HUMERAL FRACTURE. PM UP TO DATE (PASSED) AND COMPLETED POST EVENT (PASSED). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760836 DATEX/OHMEDA (GE) GIRAFFE OMNIBED ISOLETTE WARMER, INFANT RADIANT FMT DATEX/OHMEDA (GE) / DATEX-OHMEDA, INC. GIRAFFE OMNIBED

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male Other