BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3953443 · Received June 13, 2014

    Report

    Report Number
    1720753-2014-05053
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 13, 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 REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CINE BRIDGE PCB AND CINE DRIVE WERE EVALUATED AND RESEATED. THE CINE DRIVE WAS 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 A CINE DRIVE ERROR MESSAGE. 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
    349440 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1