BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA UNITY

    MDR report key: 22139632 · Received June 4, 2025

    Report

    Report Number
    3015232217-2025-00015
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 10, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    05060191071598
    PMA / PMN Number
    K212114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED ARCING IN THE MAGNET BORE. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ON (B)(6) 2025, DURING RADIATION THERAPY TREATMENT OF A PATIENT, A SCAN ABORT OCCURRED, TRIGGERED BY A RISK CONTROL MEASURE THAT ABORTS THE SCAN IF A CURRENT ERROR IS DETECTED IN THE GRADIENT AMPLIFIER. THE SCAN WAS RESTARTED AFTER THIS ABORT. DURING SCANNING THE USER NOTICED SMOKE EMERGING FROM THE SYSTEM COVERS VIA THE PATIENT OBSERVATION CAMERAS, AND THE PATIENT TRIGGERED THE NURSE CALL VIA THE HANDHELD SWITCH/BUTTON. THE USER EVACUATED THE PATIENT FROM THE TREATMENT ROOM. NO INJURY HAS BEEN REPORTED. THE MARLIN 1.5T IS AN INTEGRATED COMPONENT OF THE ELEKTA UNITY MR-LINAC SYSTEM. PHILIPS IS THE MANUFACTURER OF THE MARLIN 1.5T. ELEKTA IS THE LEGAL MANUFACTURER OF THE UNITY MR-LINAC SYSTEM AND HAS OVERALL RESPONSIBILITY FOR THE FINISHED MEDICAL DEVICE. THE ROOT CAUSE HAS BEEN IDENTIFIED BY PHILIPS AS FOLLOWS: THE CONNECTIONS BETWEEN THE BUSBARS AND THE GRADIENT COIL WERE NOT INSTALLED ACCORDING TO THE INSTRUCTIONS. STAINLESS STEEL NORD-LOCK WASHERS HAVE BEEN FOUND BETWEEN THE BUSBARS AND THE GRADIENT COIL TERMINALS INSTEAD OF ON TOP OF THE BUSBAR, WHICH FACILITATED THE OVERHEATING AND LOOSENING OF THE CONNECTIONS. EVENTUALLY THE CONDUCTING PATH BETWEEN THE BUSBARS AND GRADIENT COIL TERMINALS WAS REDUCED TO AN EXTENT WHERE ARCING OCCURRED, WHICH LED TO THE DEVELOPMENT OF SMOKE AND THERMAL DAMAGE TO THE SYSTEM. ELEKTA PERFORMED A RISK ASSESSMENT AND ASSESSED THE SEVERITY OF HARM TO BE "SERIOUS" AND PROBABILITY TO BE "IMPLAUSIBLE". THE RISK ASSESSMENT CONCLUDED THAT THE RISK IS CONSIDERED LOW. AN IMPORTANT SAFETY NOTICE (FCO) 200-01-801-012 WAS SUBMITTED TO ALL AFFECTED CUSTOMERS ON 04/04/2023. THIS WAS THEN SUPERSEDED ON 20/06/2023 WITH FCO 200-01-801-013 AND THEN ON 14/08/2025 THIS FCO WAS SUPERSEDED WITH FCO 200-01-801-016.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ARCING IN THE MAGNET BORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529852 ELEKTA UNITY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 05060191071598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown