BEUDAMED
    FDA Adverse Event Summary report: N

    XVI

    MDR report key: 3129179 · Received May 24, 2013

    Report

    Report Number
    9617016-2013-00007
    Date Received
    May 24, 2013
    Date of Event
    May 16, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K100115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE PROBLEM WAS USER ERROR AND FAILURE TO FOLLOW INSTRUCTIONS. THERE ARE SUFFICIENT WARNINGS AND MANUALS IN PLACE TO GUIDE AND WARN THE CLINICAL USER OF SELECTING THE CORRECT PRESET PRIOR TO KV ACQUISITION. NO FURTHER ACTIONS INTENDED BY THE MANUFACTURER. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS INCIDENT IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETE, ELEKTA WILL FORWARD ADDITIONAL INFORMATION TO THE FDA.

    Description of Event or Problem · 1

    A PATIENT RECEIVED STANDARD TANGENT BREAST TREATMENT. THE THERAPIST LOADED THE WRONG REFERENCE DATA FOR A PATIENT AND THEN BROKE THE SYNERGISTIQ WORKFLOW WHEN THE SYSTEM INFORMED THEM THAT THE CORRECT REFERENCE WAS NOT THERE. THEY THEN MADE A SHIFT AGAINST AN INCORRECT ISOCENTRE. THIS OCCURRED FOR TWO FRACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231193 XVI DIGITAL IMAGER, RADIATION THERAPY, IYE ELEKTA LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other