BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX-E LEGACY

    MDR report key: 4906261 · Received July 10, 2015

    Report

    Report Number
    2126677-2015-00012
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    GE MEDICAL SYSTEMS LLC
    Product Code
    IXR
    PMA / PMN Number
    K973039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION OF THIS ISSUE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS COMPLETED AND THE ROOT CAUSE WAS DETERMINED TO BE A SERVICE INSTALLATION ERROR AS THE INSTALLER FAILED TO REMOVE THE PLASTIC NOSE CONE AND INSTALL THE SAFETY STOP DURING THE INITIAL INSTALLATION OF THE SYSTEM. TO CORRECT THE SYSTEM, THE PLASTIC NOSE CONE WAS REMOVED AND THE SAFETY STOP WAS INSTALLED. IN ADDITION, IT WAS ALSO IDENTIFIED THE INSTALLER WAS INVOLVED IN ONE OTHER SYSTEM INSTALLATION. THAT SITE WAS CHECKED AND IT WAS CONFIRMED TO HAVE THE SAFETY STOP INSTALLED CORRECTLY. LASTLY, THE INSTALLER WAS NOTIFIED OF THE ERROR AND REMINDED TO REMOVE THE PLASTIC CONE AND INSTALL THE SAFETY STOP. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE TECHNOLOGIST PULLED THE FLUOROSCOPIC IDD SPOT FILM DEVICE OVER THE PATIENT TO START AN EXAM, THE IDD DETACHED FROM THE BEARING TRACK. THE TECHNOLOGIST WAS ABLE TO HOLD THE IDD UP WHILE IT RESTED ON THE BEARING TRACK UNTIL THE PATIENT WAS REMOVED FROM THE EXAM TABLE. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450022 ADVANTX-E LEGACY RADIOGRAPHIC TILTING TABLE IXR GE MEDICAL SYSTEMS LLC 2118104-3

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR