BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 19219117 · Received May 1, 2024

    Report

    Report Number
    3015232217-2024-00017
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 2, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ACCORDING TO THE SOFTWARE LOGS, A FIELD WAS ENTERED FOR TREATMENT. AFTER A BEAM ON STATE WAS DETECTED, A "DOSE DIFF" ERROR OCCURRED ON THE LINAC. AT THIS POINT, MOSAIQ RECEIVED A COUNT OF 577.2 MU FROM THE MACHINE AS HAVING BEEN DELIVERED AND 577.2 WAS RECORDED IN MOSAIQ. THE DATA RECEIVED BY MOSAIQ FOR RECORDING SHOWS A LARGE JUMP IN MU REPORTED FROM 351.7 MU IN SEGMENT 131 TO 577.2 MU IN SEGMENT 132 WHEN THE TREATMENT WAS ENDED. THE CUSTOMER STATED THAT 355 MU WAS DELIVERED WHICH IS CLOSE TO 351.7 MU. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED. IT CAN ONLY RECORD WHAT IT RECEIVES FROM THE LINAC. THE SDD LOGS HAVE NOT BEEN PROVIDED BY THE CUSTOMER TO VERIFY THE MU ADMINISTERED WHEN THE DOSE DIFFERENCE OCCURRED. A DETERMINATION REGARDING THE IMPACT TO THE PATIENT CANNOT BE MADE WITHOUT THE SDD LOGS COVERING THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT MOSAIQ DID NOT ASK HOW MANY UNITS WERE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138142 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown