BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2935251 · Received January 14, 2013

    Report

    Report Number
    1720753-2013-00627
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE CINE DRIVE AND SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CINE DISK PROBLEM. A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS MAY RESULT IN DAMAGED VASCULATURE, OR TERMINATION/RESCHEDULING OF AN INTERVENTIONAL PROCEDURE. THERE WAS NOT PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21318 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1