BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2193169 · Received July 22, 2011

    Report

    Report Number
    1720753-2011-20305
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 22, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE MAINFRAME POWER SUPPLY OUTPUT AND THE WORKSTATION POWER SUPPLY VOLTAGES WERE INCREASED. THE INTERCONNECT CABLE, THE RECEPTACLE AND THE HIGH VOLTAGE CABLE CONNECTIONS WERE INSPECTED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE SYS WOULD NOT CAPTURE FLUOROSCOPIC IMAGES AND WAS NOT FUNCTIONING AS INTENDED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1