BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3823393 · Received March 26, 2014

    Report

    Report Number
    1720753-2014-02700
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 26, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CONTROL PANEL ENCODER PCB AND PS2 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 FSE REPORTED INTERMITTENT COMMUNICATION FAILURE ERROR MESSAGES. THIS ERROR RESULTS IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176505 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 6800

    Patients

    Seq Age Sex Outcome Treatment
    1