BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 23776975 · Received December 11, 2025

    Report

    Report Number
    3015232217-2025-00074
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 11, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002282
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED A "BEAM ON" HANGING STATUS. THE INVESTIGATION FOUND THAT DURING THE TREATMENT DELIVERY, THERE WERE INTERRUPTIONS IN COMMUNICATION. THE WORKSTATION LOCKED-UP AND THE TREATMENT WAS NOT RECORDED. THE PRESCRIBED TREATMENT IS DELIVERED, AS INTENDED; HOWEVER, THE SEQUENCER APPLICATION IS NO LONGER IN OPERATION TO RECEIVE THE TREATMENT VERIFICATION AND RECORD THE PROVIDED TREATMENT INFORMATION. REVIEW OF THE RECORD, USER MESSAGES, AND/OR IN OPERATION OF THE SOFTWARE WILL MAKE CLEAR TO THE USER THAT THE PROVIDED TREATMENT HAS NOT BEEN RECORDED. AS THE TREATMENT IS DELIVERED AS PRESCRIBED, NO SERIOUS INJURY OR DEATH OCCURS, NOR WOULD EITHER BE FORESEEABLE IF THE EVENT WERE TO RECUR. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND IS WORKING AS DESIGNED AND INTENDED.

    Additional Manufacturer Narrative · 0

    H4: 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A "BEAM ON" HANGING STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2771652 MOSAIQ MOSAIQ ONCOLOGY INFORMATION SYSTEM IYE ELEKTA SOLUTIONS AB VERSION 2.81.070 00858164002282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown