BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 6600

    MDR report key: 1152864 · Received September 10, 2008

    Report

    Report Number
    1720753-2008-22203
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    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 REPAIRED THE SYSTEM, NO DETAILS ON REPAIR ARE AVAILABLE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM SHUTS DOWN AFTER 30 MINUTES OF USAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 6600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1