BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1152927 · Received September 10, 2008

    Report

    Report Number
    1720753-2008-22253
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED THE WORKSTATION PCBS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR IMAGE QUALITY AFTER INITIAL BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1