BEUDAMED
    FDA Adverse Event Other Summary report: N

    XVI

    MDR report key: 3070208 · Received April 16, 2013

    Report

    Report Number
    9617016-2013-00004
    Event Type
    Other
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    PMA / PMN Number
    K100115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE LOSS OF THE IMAGES WAS NOT FULLY TRACED, THERE WERE SOME WINDOWS EVENT LOGS THAT DID SHOW NETWORK ISSUES BEING EXPERIENCED BY THE SYSTEM; NONE OF THESE EVENTS COINCIDED WITH THE TIMING OF THE EVENT IN QUESTION. THE FINAL RISK ASSESSMENT ASSESSED THE RISK AS BEING COMPARABLE WITH OTHER RISKS THAT ARE ALREADY ACCEPTED DUE IN THE MAIN TO EFFECT ON IMAGE QUALITY ON REGISTRATION AND THAT THE LIKELIHOOD IN THIS RESULTING IN AN INCIDENT WAS LOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN SENDING A REFERENCE CT AND CONTOURS AND TREATMENT PLAN FROM (B)(6), NOT ALL OF THE CT SLICES WERE IMPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163814 XVI DIGITAL IMAGER, RADIATION THERAPY IYE ELEKTA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1