BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3942030 · Received March 5, 2014

    Report

    Report Number
    1720753-2014-02012
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 16, 2014
    Report Date
    March 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CINE DISK WAS EVALUATED AND REFORMATTED. 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 CINE FUNCTION WAS NOT OPERATING. THIS RESULTED IN LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131544 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1