BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNI BED

    MDR report key: 5093864 · Received September 22, 2015

    Report

    Report Number
    5093864
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 16, 2015
    Manufacturer
    GE HEALTHCARE LLC
    Product Code
    FMZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GIRAFFE INCUBATOR MATTRESS; WHEN POSITIONED AT OPTIMAL ELEVATION FOR VENT ASSOCIATED PNEUMONIA PREVENTION (20-30%) (EVIDENCE BASED) THE DOOR TO ACCESS THE PATIENT IS BLOCKED AND THEREFORE NOT USABLE. USE OF THIS BED PREVENTS ABILITY TO PERFORM EVIDENCE BASED BEST PRACTICE FOR HEAD OF BED ON INTUBATED NEONATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624315 GIRAFFE OMNI BED INCUBATOR, NEONATAL FMZ GE HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1