BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX-E LC+

    MDR report key: 2958200 · Received February 6, 2013

    Report

    Report Number
    9611343-2013-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZO
    PMA / PMN Number
    K931049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE¿S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGES ON THE EXAM ROOM LIVE MONITOR WERE FLICKERING. 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 PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49680 ADVANTX-E LC+ ANGIOGRAPHIC X-RAY SYSTEM IZO GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1