BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1001352 · Received February 22, 2008

    Report

    Report Number
    1720753-2008-16346
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 21, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE GENERATOR INTERFACE PCB, FLUORO FUNCTIONS PCB, AND FOOT SWITCH. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYSTEM WOULD QUIT DISPLAYING IMAGES IF MOVED DURING FLUORO. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1