BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 960657 · Received May 8, 2007

    Report

    Report Number
    1720753-2007-00552
    Event Type
    Malfunction
    Date Received
    May 8, 2007
    Date of Event
    April 9, 2007
    Report Date
    May 8, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SVC REP INVESTIGATED THE SYS AND COULD DUPLICATE THE ERROR. NONE OF THE SAVED IMAGES ON THE SYS DISPLAYED THIS IMAGE QUALITY ISSUE. THE ISSUE WAS SPECIFIC TO THE LIVE IMAGE DISPLAY ONLY. THE IMAGE PROCESSING OCB WAS RELOCATED TO A DIFFERENT SLOT ON THE SYS BACKPLANE AND A VIDEO CABLE WAS RE-CLIPPED AND SECURED. THE ISSUE WAS RESOLVED AND THE SYS WAS TESTED AND FOUND TO BE OPERATING AS INTENDED. THE SYS WAS RELEASED TO THE CUSTOMER FUNCTIONING AS INTENDED. THERE WAS NO NEGATIVE EFFECT ON ANY PTS AS A RESULT OF THIS ISSUE. THE FACILITY WAS UNABLE, OR COULD NOT PROVIDE ANY RELEVANT PT INFO PERTAINING TO THIS SYS ISSUE.

    Description of Event or Problem · 1

    THE GE OEC 9600 FLUOROSCOPY SYS HAD IMAGE QUALITY ISSUES WITH LINES ACROSS BOTH THE LEFT AND RIGHT MONITORS, AND TEXT ON IMAGES THAT WAS UNREADABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9600 C-ARM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *