BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1322374 · Received February 24, 2009

    Report

    Report Number
    1720753-2008-29149
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    November 19, 2008
    Report Date
    December 15, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RE-SEATED CIRCUIT BOARDS AND CONNECTORS. SYSTEM OPERATES AS INTENDED. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1