BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3832631 · Received March 27, 2014

    Report

    Report Number
    1720753-2014-02728
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CINE DRIVE WAS EVALUATED, REPLACED 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 A CINE DISK NOT AVAILABLE 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
    179454 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1