BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3962956 · Received June 11, 2014

    Report

    Report Number
    1720753-2014-04940
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 11, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CELERON UPGRADE KIT WAS INSTALLED. THE SYSTEM INTERFACE, PASSIVE BACKPLANE, IMAGE PROCESSOR, CINE DRIVE, MAINFRAME BACKPLANE, GENERATOR INTERFACE AND FLUORO FUNCTIONS BOARDS WERE INSTALLED 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

    THE FE REPORTED A CINE ERROR APPEARED ON WORKSTATION AFTER BOOTUP. A LOSS OF CINE, SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR FUNCTIONS COULD RESULT IN DELAY OR TERMINATION/RESCHEDULING OF AN INTERVENTIONAL PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345031 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1