BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 7047857 · Received November 21, 2017

    Report

    Report Number
    2950347-2017-00013
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Report Date
    November 20, 2017
    Manufacturer
    ELEKTA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INVESTIGATION, IT HAS BEEN CONFIRMED THAT NO TREATMENT OCCURED UNDER THE REPORT INCIDENT CONDITIONS. THE REPORTED INCIDENT CONDITIONS HAVE NOT BEEN REPEATABLE BY THE CUSTOMER OR ELEKTA. NO PATIENT HAS BEEN MISTREATED, AND NO ERRONEOUS IRRADIATION HAS OCCURED. THE CUSTOMER HAS BEEN ASKED TO PROVIDE PICTURES AND ADDITIONAL INFORMATION IF THIS OCCURS AGAIN. MFR REPORT NUMBER CORRECTION PLEASE NOTE THAT THIS INFORMATION HAS PREVIOUSLY BEEN SUBMITTED AS AN INITIAL AND FOLLOW-UP REPORTS UNDER AN INCORRECT MFR REPORT NUMBER. THESE WERE SUBMITTED AS FOLLOWS: 0290347-2017-00013 INITIAL REPORT, SUBMITTED 03-AUGUST-2017, SUBMITTED ELECTRONICALLY. 0290347-2017-00013 FOLLOW-UP REPORT #1, SUBMITTED 03-NOVEMBER-2017, SUBMITTED ELECTRONICALLY. AS A RESULT OF SUBMITTING THESE TWO REPORTS WITH AN INCORRECT MFR REPORT NUMBER, THE TWO HAVE BEEN MERGED AND RESUBMITTED IN THIS REPORT UNDER THE CORRECT MFR REPORT NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY SET THE MOSAIQ DIAGNOSIS AND TREATMENT SCREEN TO NOT DISPLAY AS THEY DID NOT WANT THE FIELD TO IRRADIATE, HOWEVER, IT WAS DISPLAYED ON THE TREATMENT EXECUTION SCREEN AT THE TIME OF TREATMENT. NORMALLY, WHEN IT IS SET TO NOT BE DISPLAYED, IT IS NOT DISPLAYED ON THE TREATMENT EXECUTION SCREEN ALSO. IT IS BELIEVED THE CUSTOMER WAS NOT USING THE TREATMENT CALENDAR, WHICH THE CUSTOMER HAS BEEN ADVISED TO USE IN ACCORDANCE WITH THE USER'S MANUAL. IF THIS CALENDAR WAS IN USE, THE USER WOULD BE REQUIRED TO INPUT THEIR ID AND PASSWORD FOR THE DISPLAY TO BE OFF DURING IRRADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830689 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1