BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA INFINITY

    MDR report key: 23523115 · Received November 11, 2025

    Report

    Report Number
    3015232217-2025-00070
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K210500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE EXECUTION OF A PULSE FORMING NETWORK (PFN) INSPECTION ASSOCIATED WITH FIELD CHANGE ORDER (FCO) 200-06-103-099, A FIELD SERVICE ENGINEER (FSE) EXPERIENCED AN ELECTRICAL SHOCK. THE INCIDENT OCCURRED WHEN THE FSE INADVERTENTLY OMITTED THE ATTACHMENT OF THE CONDUCTOR ROD WHILE FOLLOWING THE "PFN REPLACEMENT PROCEDURE." AS A RESULT, THE FSE CAME INTO CONTACT WITH THE BAR LOCATED AT THE BOTTOM OF THE PFN, LEADING TO AN ELECTRICAL SHOCK AND TINGLING SENSATIONS IN BOTH HANDS. THE FSE ALSO FELL FROM A LADDER DURING THE EVENT BUT DID NOT SUSTAIN ANY INJURIES. FOLLOWING THE INCIDENT, THE FSE ATTENDED THE EMERGENCY ROOM FOR MEDICAL EVALUATION. AFTER ASSESSMENT BY A PHYSICIAN, NO FURTHER TREATMENT WAS DEEMED NECESSARY. THERE WAS NO PRODUCT MALFUNCTION. THE ROOT CAUSE OF THE INCIDENT WAS IDENTIFIED AS USE ERROR, SPECIFICALLY THE FAILURE TO CORRECTLY FOLLOW PROCEDURAL STEPS OUTLINED IN THE PFN REPLACEMENT PROCEDURE. THE FOLLOWING ACTIONS HAVE BEEN IMPLEMENTED TO HELP PREVENT RECURRENCE OF THE INCIDENT: 1. FIELD SERVICE ENGINEER (FSE) HAS COMPLETED WEB-BASED TRAINING: 2. A SENIOR FIELD SERVICE ENGINEER HAS CONDUCTED RETRAINING WITH THE FSE, SPECIFICALLY FOCUSING ON THE PFN FCO PROCEDURE.

    Description of Event or Problem · 0

    AN ELEKTA FIELD SERVICE ENGINEER SUFFERED AN ELECTRICAL SHOCK WHILE COMPLETING FCO 200-06-103-099.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2524339 ELEKTA INFINITY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male