BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX LCA

    MDR report key: 2220059 · Received August 9, 2011

    Report

    Report Number
    9611343-2011-00058
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    March 31, 2011
    Report Date
    August 9, 2011
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K945375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    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 FRONTAL PLANE MONITOR WERE FLICKERING INTERMITTENTLY DURING FLUOROSCOPY EXPOSURE. THE USER STATED THAT WHEN THE MONITOR WAS FLICKERING, THE IMAGES WERE UNUSABLE. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX LCA ANGIOGRAHPHIC X-RAY SYSTEM IZI GE MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1