BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3190052 · Received June 18, 2013

    Report

    Report Number
    1720753-2013-07348
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED AND AN FFB NODE SOFTWARE RELOAD WAS PERFORMED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED A GENERATOR FAULT AND A LOSS OF COMMUNICATION BETWEEN THE WORKSTATION AND THE MAINFRAME. THIS LIKELY RESULTED IN A SYSTEM LOCK-UP, BO BOOT, OR SHUT DOWN. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276572 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1