BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 6800

    MDR report key: 1232529 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-28030
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 10, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED (+5, +24, -12) POWER SUPPLY, GENERATOR BACKPLANE, AND I/O TRANSITION PCB. SYSTEM OPERATES AS INTENDED. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INTERMITTENT X-RAYS DISABLED AND GENERATOR SHUTDOWN ERRORS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 6800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1