BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 857638 · Received May 31, 2007

    Report

    Report Number
    1720753-2007-01437
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 31, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REPRESENTATIVE WAS INVESTIGATING THE ISSUE AND REPLACED THE IMAGE PROCESSOR OCB, THE GENERATOR BATTERIES, AND THE POWER CORD. THE SYSTEM WAS 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 INFO WITH RESPECT TO THIS ISSUE.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYSTEM HAD REPORTED POOR IMAGE QUALITY DURING A PROCEDURE. GRAINY IMAGES. PT REPORTED LARGE.

    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