BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3093409 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05396
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RECONFIGURED THE SYSTEM TO WORK WHILE AWAITING CUSTOMER APPROVAL OF QUOTE FOR REPLACEMENT OF THE CINE DRIVE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A 'CINE DISK NOT AVAILABLE' ERROR. THIS WOULD PREVENT THE CINE FUNCTION FROM OPERATING. A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS COULD RESULT IN UNDUE PT DELAY OR DAMAGED VASCULATURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181658 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1