BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4142636 · Received September 26, 2014

    Report

    Report Number
    1720753-2014-08246
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 26, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE VOLTAGE ON PS1 WAS EVALUATED AND READJUSTED TO OPTIMUM OPERATING VOLTAGE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM FAILED TO GENERATE FLUOROSCOPY X-RAY ATTRIBUTED TO COMMUNICATE ERROR MESSAGE DISPLAY. THIS WAS RESOLVED BY REBOOTING THE SYSTEM. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601046 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1