BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4122152 · Received September 19, 2014

    Report

    Report Number
    1720753-2014-08025
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS(SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. A COMPLETE SBS UPGRADE WAS INSTALLED. THE BACKPLANE MOUNT, BACKPLANE, SYSTEM INTERFACE, VIDEO CONTROLLER BOARD, SMART SWITCH ASSEMBLY, IMAGE PROCESSOR BOARD, GIB AND FFB BOARDS WERE EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP ATTRIBUTED TO A COMMUNICATION ERROR MESSAGE DISPLAY. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583147 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS(SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1