BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1921538 · Received December 7, 2010

    Report

    Report Number
    1720753-2010-04494
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE XRAY TUBE, BATTERY PACK, AND HIGH VOLTAGE CABLE WERE REPLACED. ALSO, A GENERATOR CALIBRATION WAS PERFORMED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED. THIS INCIDENT MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED SEVERAL ERROR CODE MESSAGES. NO REPORT OF PATIENT OR STAFF INJURY.

    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