BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA MEDICAL GIRAFFE OMNIBED

    MDR report key: 488390 · Received October 9, 2003

    Report

    Report Number
    1121732-2003-00006
    Event Type
    Malfunction
    Date Received
    October 9, 2003
    Date of Event
    September 10, 2003
    Report Date
    October 7, 2003
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Removal / Correction Number
    Z-0409/0410-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ELEVATING BASE OF THE SUBJECT DEVICE MOVED WITHOUT USER ACTIVATION WHILE A PT WAS BEING TREATED ON HFOV IN THE UNIT. THERE WAS NO ADVERSE EFFECT ON THE PT. THE PROBLEM WAS SOLVED BY REPLACING THE FOOTSWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA MEDICAL GIRAFFE OMNIBED INFANT INCUBATOR FMZ OHMEDA MEDICAL OMNIBED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other HFOV - HIGH FRECUENCY OSCILLATOR VENTILATOR.