BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 515117 · Received January 23, 2004

    Report

    Report Number
    1121732-2004-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2004
    Date of Event
    November 4, 2003
    Report Date
    January 23, 2004
    Manufacturer
    GE MEDICAL SYSTEMS/OHMEDA MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCIDENT OCCURRED IN 2003 DURING PATENT DUCTOUS ARTERIOSIS (PDA) SURGERY ON PT, IN WHICH DURING USE OF ELECTROSURGICAL UNIT, THE OHMEDA MEDICAL GIRAFFE OMNIBED ALARMS WERE TRIGGERED AND COULD NOT BE SILENCED. THE OMNIBED EXHIBITED SYSTEM FAILURE 7 AND SYSTEM FAILURE 5. THE USER ATTEMPTED TO SILENCE THE ALARM BY CYCLING POWER ON AND OFF AND THE ELEVATING BASE DESCENDED SLOWLY SEVERAL INCHES. THERE WAS NO REPORTED PT INJURY. THE INCIDENT APPEARED TO BE CAUSED BY THE USE OF THE RF GENERATING ELECTRO-SURGICAL UNIT DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE OMNIBED INFANT INCUBATOR FMZ GE MEDICAL SYSTEMS/OHMEDA MEDICAL OMNIBED *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Other