BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4861743 · Received June 19, 2015

    Report

    Report Number
    1720753-2015-02521
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 19, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE LEMO CONNECTOR AND THE REAL TIME OPERATING SYSTEM (RTOS) WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED A COMMUNICATION FAILURE ERROR MESSAGE AND LOCKED UP. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398958 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900 E2-0466

    Patients

    Seq Age Sex Outcome Treatment
    1