BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4240016 · Received November 3, 2014

    Report

    Report Number
    1720753-2014-09109
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 15, 2014
    Report Date
    November 3, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ON SITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT DISPLAY A FLUOROSCOPIC IMAGE. THERE IS NO RESULT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704042 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1