BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 862722 · Received June 8, 2007

    Report

    Report Number
    1720753-2007-01849
    Event Type
    Malfunction
    Date Received
    June 8, 2007
    Date of Event
    May 14, 2007
    Report Date
    June 10, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REP INVESTIGATED THE ISSUE AND ISOLATED THE MALFUNCTION TO A DEFECTIVE GENERATOR INTERFACE (GIB) FCB. THE GIB WAS REPLACED. ADDITIONALLY, PINS IN THE INTERCONNECT LEMO RECEPTACLE WERE RE-SEATED. THE DESCRIBED ISSUE APPEARS TO BE A SYSTEM LOCK-UP WHERE THE INTERLOCKS OPEN AND THE SYSTEM REMAINS IN-STATE UNTIL REBOOT, ALTHOUGH IT APPEARS TO CONTINUE MAKING X-RAYS, ALTHOUGH GENERALLY, NO RADIATION IS PRODUCED. THE SYSTEM WAS FURTHER TESTED AND FOUND TO BE OPERATING AS INTENDED. NO NEGATIVE PT EFFECT WAS CAUSED BY THIS MALFUNCTION. THE FACILITY WAS UNABLE OR WOULD NOT PROVIDE ANY PT INFORMATION WITH RESPECT TO THIS ISSUE.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYSTEM APPEARED TO CONTINUE MAKING X-RAYS AFTER THE HAND OR FOOTSWITCH WAS RELEASED. RE-BOOTING THE SYSTEM WOULD RESTORE SYSTEM FUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR