BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2940990 · Received January 31, 2013

    Report

    Report Number
    1720753-2013-01330
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 31, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CIRCUIT BOARDS WERE RESEATED AND THE CINE DRIVE WAS REFORMATTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A CINE NOT AVAILABLE ERROR MESSAGE. THE CINE FUNCTION WAS NOT WORKING, RESULTING IN A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43148 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1