BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2192889 · Received July 25, 2011

    Report

    Report Number
    1720753-2011-20343
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CONTROLLER PRINTED CIRCUIT BOARD WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A SYSTEM ERROR CODE WHICH RESULTED IN A LOSS OF FUNCTIONALITY. THERE WAS NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1