BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBEAT

    MDR report key: 23819382 · Received December 16, 2025

    Report

    Report Number
    1000162206-2025-00003
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    September 15, 2022
    Report Date
    December 16, 2025
    Manufacturer
    HITACHI,LTD.
    Product Code
    LHN
    PMA / PMN Number
    K053280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REASON FOR THE BLANK OF FIELD D.4: THIS DEVICE HAS BEEN INSTALLED IN ONLY ONE PLACE IN THE UNITED STATES, THUS THE SUBJECT DEVICE CAN BE IDENTIFIED. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S MDR FILING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF LEGACY MDRS.

    Description of Event or Problem · 0

    MAINTENANCE WORKERS REMOVED THE NOZZLE COVER IN GANTRY ROOM 1 TO INVESTIGATE THE NOZZLE ON SEP. 14TH NIGHT. THE WORKERS PUT THE COVER BACK ON THE NOZZLE. DURING PATIENT'S TREATMENT IN THE NEXT MORNING, NOZZLE COVER DROPPED SUDDENLY. THE THERAPIST STOPPED THE GANTRY ROTATION AND THERE WAS NO INJURY TO THE PATIENT. AS A RESULT OF THE INVESTIGATION, IT WAS FOUND THAT THE EVENT WAS CAUSED BY INSTALLING THE COVER TO INCORRECT POSITION WHEN THEY ATTACHED THE COVER. THE OTHER MAINTENANCE WORKERS REINSTALLED THE COVER IN THE CORRECT POSITION AND CHECKED WITH THE GANTRY ROTATION. IN ADDITION, THE SITE MANAGER CONDUCTED THE REFRESH TRAINING FOR MAINTENANCE WORKERS FOR PREVENTING ECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206005 PROBEAT PROTON BEAM THERAPY SYSTEM LHN HITACHI,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown