BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1173217 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26035
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SVC REP RESEATED THE HV CABLES, RESEATED THE GIB BOARD, AND CHECKED CONNECTIONS ON THE FILAMENT DRIVER AND GENERATOR DRIVER BOARD. HE COULD NOT DUPLICATE THE PROBLEM. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SOUNDED AS THOUGH IT WAS MAKING EXPOSURE, BUT THE SCREEN WAS BLANK. THE CUSTOMER REBOOTED THE SYSTEM AND COMPLETED THE CASE WITH NO FURTHER PROBLEMS. THERE WAS ALSO A MA SENSOR ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1