BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 23377282 · Received October 24, 2025

    Report

    Report Number
    3015232217-2025-00067
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 22, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    07340201500071
    PMA / PMN Number
    K223229
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11 UPDATED: THE CUSTOMER REPORTED A COMPLETION PLAN DELIVERY ERROR. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCTS AND THE REPORTED INFORMATION. A TREATMENT PLAN NAMED ADRPTNNNADT06 WAS INTENDED TO BE DELIVERED ON THE DAY OF THE INCIDENT. THE DELIVERY OF THIS PLAN WAS INTERRUPTED WHEN A "BEAM INTERRUPT" WAS EXPERIENCED ON THE LINAC. A COMPLETION PLAN WAS ATTEMPTED, THIS PLAN WAS CALLED ADRPTNNNCP06. DUE TO DIFFICULTIES WITH PATIENT SET-UP, THIS PLAN ADRPTNNNCP06 WAS NOT DELIVERED. ANOTHER VERSION OF THIS PLAN, CALLED ADRPTNNNACP09 WAS CREATED AND USED TO DELIVER FIELDS 2-5. ADRPTNNNACP09 WAS CREATED USING OPTIMIZE WEIGHTS AND SHAPES AND ENDED UP WITH SLIGHTLY DIFFERENT MU THAN ADRPTNNNCP06. HOWEVER, THE DOSE DISTRIBUTIONS ARE QUITE CLOSE AND THIS PLAN IS APPROVED SO IT IS ASSESSED AS BEING CONSISTENT WITH THE INTENDED DELIVERY. FOLLOWING THIS, FIELDS 6-10 FROM ADRPTNNNCP06 WERE DELIVERED ON ANOTHER DAY, EFFECTIVELY COMPLETING THE INTENDED TREATMENT. ELEKTA PHYSICS HAVE ASSESSED THIS INCIDENT AND CONCLUDED THAT THERE WAS NO MISTREATMENT. THE SUM OF THE DOSE FROM ALL FIELDS AS TREATED IS CONSISTENT WITH THE ORIGINAL INTENDED PLAN (I.E. ADRPTNNNADT06) AFTER ACCOUNTING FOR USER APPROVED ADAPTATION AND COMPLETION PLAN VARIATIONS. BASED ON AVAILABLE INFORMATION THERE WAS NO MISTREATMENT. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS 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. H11: 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 COMPLETION PLAN DELIVERY ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242029 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB VERSION 3.2.2.0 07340201500071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown