BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3905577 · Received May 28, 2014

    Report

    Report Number
    1720753-2014-04510
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    September 16, 2013
    Report Date
    May 28, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE CINE FUNCTION WAS NOT OPERATING PROPERLY. 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
    314822 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1