BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3982770 · Received July 24, 2014

    Report

    Report Number
    1720753-2014-06370
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 25, 2014
    Manufacturer
    GE OE MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE KEY ASSEMBLY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTED AN INTERMITTENT X-RAY DISABLED ERROR MESSAGE. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434890 9800 FLUOROSCOPIC X-RAY JAA GE OE MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1