BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 4152298 · Received October 2, 2014

    Report

    Report Number
    1720753-2014-08361
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE, HIGH VOLTAGE CABLE, LEMO CONNECTION, GENERATOR INTERFACE PCB AND FLUOROSCOPIC FUNCTIONS PCB WERE EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO DISPLAY FLUOROSCOPIC EXPOSURES AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614034 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1