BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2101616 · Received May 11, 2011

    Report

    Report Number
    1720753-2011-07196
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 11, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REP REPLACED THE BRAKE PAD, BOTH THE LOCKING WHEELS AND CALIBRATED THE FILAMENT AS WELL AS TESTED THE BATTERIES AND FILED THE ROUGH EDGES ON THE C-ARM. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR ERROR MESSAGE. 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