BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4253411 · Received November 12, 2014

    Report

    Report Number
    1720753-2014-09258
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 12, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE GPOS BOARD AND CINE BRIDGE PCB 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

    IT IS REPORTED THE SYSTEM DISPLAYED AN INTERMITTENT CINE DRIVE IS NOT AVAILABLE ERROR. THIS WOULD PREVENT THE CINE FUNCTION FROM OPERATING, CAUSING A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729047 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1