BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1173019 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26118
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP OBSERVED THE PREVIOUS IMAGES. HE SUSPECTED PATIENT MOVEMENT. THE GE REP FOUND ARTIFACTS ON IMAGES AND FOUND THAT THE CONTRAST SPILLED AND DRIED ON COLLIMATOR COVER. THE GE REP CLEANED THE COVER AND REMOVED THE ARTIFACTS. HE CHECKED THE IMAGE RESOLUTION. ALL WERE WITHIN SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYS INTERMITTENT POOR IMAGE QUALITY. THERE WERE BLURRY IMAGES PRINTING AND IN THE SYSTEM.

    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