BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1440640 · Received August 18, 2009

    Report

    Report Number
    1720753-2009-02459
    Event Type
    Malfunction
    Date Received
    August 18, 2009
    Date of Event
    February 25, 2009
    Report Date
    March 23, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT. THE GE SVC REP RETRIEVED THE ERROR AND SHOTLOG FILES, AND SAW THE FFB AND GIB DISCONNECT. HE CHECKED VOLTAGES IN THE MAINFRAME AND WORKSTATION, ALL OK. HE CHECKED THE LEMO CONNECTOR AND INTERCONNECT CABLE, BOTH OK. HE RESEATED THE CONNECTORS ON THE GIB AND FFB PCB, RESEATED BOTH PCB BOARDS. HE USED ESD MAT ON SERVICE CALL, THEN RESEATED THE SYSTEM INTERFACE PCB AND CONNECTORS. HE COMPLETED THE TRACKING AND RESOLUTION TEST, OK. HE ORDERED PARTS AND REPLACED THE POWER SUPPLY AND VERIFIED SYSTEM IS OPERATING BY FLUOROING IN LOW AND HIGH TECHNIQUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DID NOT DISPLAY AN IMAGE ON THE SYSTEM. THE IMAGES ARE SHOOTING DARK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1