BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX LC+

    MDR report key: 2433027 · Received January 6, 2012

    Report

    Report Number
    9611343-2012-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZO
    PMA / PMN Number
    K931049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REFERENCE MDR 9611343-2011-00001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGES ON THE EXAM ROOM LIVE MONITOR WERE FLICKERING DURING FLUOROSCOPY EXPOSURES. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH WAS REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX LC+ FLUOROSCOPIC X-RAY SYSTEM IZO GE MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1