BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OCE 9800

    MDR report key: 867766 · Received June 20, 2007

    Report

    Report Number
    1720753-2007-02325
    Event Type
    Malfunction
    Date Received
    June 20, 2007
    Date of Event
    May 28, 2007
    Report Date
    June 20, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SVC REP INVESTIGATED THE ISSUE AND COULD NOT DUPLICATE THE ERROR. THE SYS WAS EXTENSIVELY EVALUATED AND THE ISSUE WAS SUSPECTED TO BE INTERMITTENT OR PROCEDURE RELATED. THE CUSTOMER WOULD MONITOR THE ISSUE AND WAS ADVISED TO CONTACT SVC IF THE IMAGE QUALITY ISSUE OCCURRED AGAIN. THE SYS WAS TESTED AND FOUND TO BE OPERATING AS INTENDED AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFO WITH RESPECT TO THIS ISSUE. NO NEGATIVE PT EFFECT WAS REPORTED BECAUSE OF THIS MALFUNCTION, THAT OCCURRED DURING A PROCEDURE.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYS REPORTEDLY HAD IMAGE QUALITY ISSUE WHERE THE BRIGHTNESS AND CONTRAST FLUCTUATED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR