BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4861744 · Received June 19, 2015

    Report

    Report Number
    1720753-2015-02520
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD WAS 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, THE SYSTEM LOCKED UP. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399392 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800 8S-2696

    Patients

    Seq Age Sex Outcome Treatment
    1