BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1070996 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-20574
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 10, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP REPLACED THE INTERCONNECT CABLE. HE CONNECTED CABLE AND UNCONNECTED CABLE SEVERAL TIMES. THE REP FOUND NO NEW CONNECTION ERRORS. CABLE TO GOUND .3 OHMS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INTERCONNECT CABLE WAS HARD TO PLUG IN AND UNPLUG. SYSTEM WOULD HAVE INTERMITTENT BOOT UP PROBLEMS. THE X-RAY TECHS WOULD REPLUG THE INTERCONNECT CABLE TO FIX PROBLEMS. IT WAS FOUND THT THE INTERCONNECT CABLE GUIDE KEYS WHERE THICKER THAN THE NEW REPLACEMENT INTERCONNECT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1