BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 24207126 · Received January 29, 2026

    Report

    Report Number
    3015232217-2026-00002
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    December 22, 2025
    Report Date
    March 9, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K183034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING DATE IS NOT ON THE LABEL, BUT IT IS KNOWN SO FIELD H4 HAS BEEN COMPLETED WITH THIS INFORMATION. THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    H11: UPDATED: THE CUSTOMER REPORTED THAT MOSAIQ RECORDED A SESSION INCORRECTLY. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ON (B)(6) 2025, FIELD 1.1 WAS ENTERED FOR TREATMENT AT 10:20:25. TREATMENT STOPPED WHEN A "BEAM MU CH1" ERROR OCCURRED ON THE MACHINE AT 10:25. MOSAIQ RECEIVED A COUNT OF 2005.7 MU FROM THE MACHINE AS HAVING BEEN DELIVERED WHICH MATCHES THE PRESCRIBED 2005.7 MU PROCESSED AND RECORDED BY MOSAIQ. THE DATA RECEIVED BY MOSAIQ FOR RECORDING THIS DELIVERY SHOWS AN UNUSUAL JUMP IN MU REPORTED BY THE LINAC FROM 1,277.5 MU TO 2,005.7 MU (SEGMENT 199 TO SEGMENT 200) WHEN TREATMENT ENDED. THE CUSTOMER EXPLAINS THAT A POWER OUTAGE OCCURRED WHILE TREATING FIELD 1.1 AND ONLY 1281 MU HAD BEEN GIVEN UP TO THAT POINT. THE SDD LOGS ARE NECESSARY TO DETERMINE WHY THE LINAC REPORTED 2005.7 MU TO MOSAIQ INSTEAD OF 1281 MU. UNFORTUNATELY, THE SDD LOGS COVERING THE EVENT ARE NOT AVAILABLE FOR REVIEW BECAUSE THEY ARE PERIODICALLY OVERWRITTEN. THE CUSTOMER HAS ALREADY MADE CHART CORRECTIONS TO SHOW THAT 1281 MU OF THE PRESCRIBED 2005.7 MU WAS GIVEN. FIELD 1.1 WAS UNDERDOSED BY 724.7 MU. ELEKTA PHYSICS HAVE ASSESSED THAT, IN THE WORST CASE WHERE THE UNDERDOSE IS NOT CORRECTED, THIS WOULD BE AN INSIGNIFICANT RADIATION OVERDOSE. MOSAIQ IS WORKING AS INTENDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT MOSAIQ RECORDED A SESSION INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77555 MOSAIQ ACCELERATOR, LINEAR, MEDICAL, PRODUCT CODE: IYE IYE ELEKTA SOLUTIONS AB VERSION 2.84.002 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown