BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1980074 · Received January 24, 2011

    Report

    Report Number
    1720753-2011-00527
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP CALLED THE CUSTOMER AND FOUND THAT THE CUSTOMER HAD BEEN FLUOROING FOR TRAINING STUDIES, AND THE SYSTEM WAS BEING RUN FOR APPROXIMATELY 2 HOURS. THE SYSTEM WAS FIRST EXHIBITING FILAMENT REGULATION ERROR, BUT CUSTOMER CONTINUED USING SYSTEM. THE SYSTEM WAS FOUND TO BE WORKING AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9800 SYSTEM HAD A FILAMENT REGULATOR ERROR AND THE IMAGE WENT BLACK. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1