BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 24113556 · Received January 20, 2026

    Report

    Report Number
    2950347-2026-00002
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    December 22, 2025
    Report Date
    February 6, 2026
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K183034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H11: UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT A PATIENT RECEIVED TREATMENT TWICE ON THE SAME ARC. THE LOGS FOR (B)(6) 2025, SHOW THAT FIELD ARC1 WAS ENTERED FOR TREATMENT VERIFICATION AT 15:33:37. THE TERMINATE KEY WAS TURNED BY THE USER TO STOP TREATMENT AFTER 160.7 MU WAS ADMINISTERED. TREATMENT RESUMED AT 15:40:02 AND 575.1 MU MORE WERE GIVEN BEFORE A "TABLE HEIGHT SERVO" ERROR ENDED DELIVERY AGAIN. AT THIS POINT, ARC1 HAD RECEIVED A TOTAL OF 735.8 MU OF THE PRESCRIBED 953.4 MU. THE REMAINING 217.6 MU WAS GIVEN LATER AROUND 15:58 TO COMPLETE THE PRESCRIBED DAILY DOSE TO FIELD ARC1. THE TREATMENT WAS RECORDED IN MOSAIQ. AFTER THIS, AT 15:59:29, THE FIELD ARC1 WAS SELECTED ONCE MORE FROM THE TREATMENT DELIVERY TABLE. THE USER WAS PRESENTED WITH A WARNING THAT THE FIELD HAD ALREADY BEEN TREATED TODAY AND CHOSE YES TO CONTINUE. MOREOVER, THE USER RECEIVED A FRACTIONAL DOSE WARNING THEN PROCEEDED TO OVERRIDE THE FRACTIONAL DOSE TO MOVE FORWARD WITH ANOTHER FULL TREATMENT OF 953.4 MU TO ARC1. FIELD ARC1 WAS TREATED TWICE ON (B)(6) 2025. IN THIS INCIDENT AN ARC WAS DELIVERED TWO TIMES IN ONE DAY INSTEAD OF THE INTENDED SINGLE TIME. THE DELIVERED DOSE FROM THE ARC WAS 3.11 GY. THE TOTAL INTENDED DAILY DOSE WAS 6.0 GY. THE TOTAL INTENDED NUMBER OF FRACTIONS WAS 10. THE REMAINING 9 FRACTIONS WERE DELIVERED AS ORIGINALLY PLANNED. THE ERROR REPRESENTS AN ~52% OVERDOSE ON THE DAY OF THE INCIDENT AND A 5.2% OVERDOSE OVER THE COURSE OF THE TREATMENT. ELEKTA PHYSICS HAVE ASSESSED THIS AS A SERIOUS RADIATION OVERDOSE. MOSAIQ WORKED AS INTENDED. THE ROOT CAUSE IS ABNORMAL USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT RECEIVED TREATMENT TWICE ON THE SAME ARC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177254 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC 2.83.053 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other