BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX LC+

    MDR report key: 3001948 · Received February 12, 2013

    Report

    Report Number
    9611343-2013-00004
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZO
    PMA / PMN Number
    K931049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4). REFERENCE MDR 9611343-2011-00001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGES ON THE EXAM ROOM LIVE MONITOR WERE FLICKERING. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62193 ADVANTX LC+ GENERATOR HIGH-VOLTAGE X-RAY DIAGNOSTIC IZO GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1