BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3871899 · Received April 17, 2014

    Report

    Report Number
    1720753-2014-03372
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GIB WAS 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 FE REPORTED GIB DISCONNECT MESSAGE IN ERROR LOG. THE CUSTOMER HAD TO REBOOT THE SYSTEM. THIS IS CONSISTENT WITH AN INTERMITTENT SYSTEM LOCKUP SITUATION. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235928 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1