BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3792479 · Received January 18, 2014

    Report

    Report Number
    1720753-2014-00611
    Event Type
    Malfunction
    Date Received
    January 18, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CINE DRIVE WAS EVALUATED AND REFORMATTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS INTERMITTENTLY LOSING CINE RUNGS; THEREBY LOSING SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR FUNCTIONS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46356 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1