BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE-OEC-6600

    MDR report key: 878955 · Received July 11, 2007

    Report

    Report Number
    1720753-2007-03105
    Event Type
    Malfunction
    Date Received
    July 11, 2007
    Date of Event
    June 17, 2007
    Report Date
    July 10, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A FAULTY CONTROLLER FCB. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT GO INTO MAG MODE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE-OEC-6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC 6600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR