BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBEAT

    MDR report key: 23819779 · Received December 16, 2025

    Report

    Report Number
    1000162206-2025-00006
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    December 6, 2016
    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 D4: THIS DEVICE HAS BEEN INSTALLED IN ONLY ONE PLACE IN THE UNITED STATES, THUS THE SUBJECT DEVICE CAN BE IDENTIFIED. PLEASE NOTE THAT: O THE MDR WAS INITIALLY SUBMITTED MISTAKENLY TO THE MDR TEST SYSTEM RATHER THAN THE REPORTING SYSTEM ON DECEMBER 30, 2016. AFTER FOLLOWING UP WITH FDA TO RECEIVE FURTHER INFORMATION REGARDING THE STATUS OF THE MDR, HITACHI IS RE-SUBMITTING THROUGH THE ELECTRONIC SUBMISSION SYSTEM. O THE COMPANY HAS NO ADDITIONAL INFORMATION SINCE THE SUBMISSION OF THAT MDR ON DECEMBER 30, 2016." 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

    BEAM FLATNESS WAS DEGRADED DUE TO THE DISPLACEMENT OF THE SECOND SCATTERER (SCC) ON (B)(6) 2016. THE MAXIMUM DISPLACEMENT OF THE SCC HAS BEEN CONFIRMED TO BE 5 MM. THE DEGRADATION OF THE FLATNESS WAS MEASURED IN THE CONDITION SCC WAS DISPLACED, THE FLATNESS CAME TO BE APPROXIMATELY +/5 PERCENT. THE WORKING FAILURE OF THE LIMIT SWITCH AND THE DISPLACEMENT OF THE LIMIT SWITCH CAUSED THE MIS-POSITION OF THE SCC. THIS EVENT WAS DETECTED IN HAPPENING AN OVER TRAVEL ERROR ON THE SCC. AN OVER TRAVEL ERROR WAS ALSO OBSERVED ON (B)(6) 2016, HOWEVER, THE ISSUE FOR BEAM FLATNESS WAS NOT RECOGNIZED AT THAT TIME BECAUSE THE SYSTEM WAS BACK TO NORMAL IN CORRECTING THE LIMIT SWITCH POSITION. THE OVER TRAVEL ERROR HAPPENED AGAIN, THE CAUSE AND THE INFLUENCE WERE WELL INVESTIGATED ON (B)(6) 2016, THUS THE ISSUE FOR BEAM FLATNESS WAS RECOGNIZED. FURTHER, THE AUTOMATIC BEAM POSITION TUNING WAS CARRIED OUT FOR THE DISPLACED SCC AND THEN THE SCC WAS RELOCATED TO THE RIGHT POSITION. THIS SITUATION IS SIMILAR TO THAT FOR THE DISPLACED SCC, THUS, THE DEGRADATION OF THE FLATNESS ALSO CONTINUED UP TO (B)(6). AS WELL AS THAT, THE DEGRADATION OF THE FLATNESS CONTINUED UP TO (B)(6) FOR THE SCC DISPLACEMENT HAPPENED ON (B)(6). AS A RESULT, 47 FIELDS IN THE TREATMENTS WERE PERFORMED IN THE DEGRADED FLATNESS STATE IN (B)(6). REGARDING THE FIELDS PER PATIENT, THREE FIELDS AT MOST FOR A CERTAIN PATIENT WERE CARRIED OUT IN DEGRADED FLATNESS. IN GENERAL, A TREATMENT OF TOTAL 10 TO 30 FRACTIONS PER PATIENT ARE CARRIED OUT, AND ONE FRACTION COMPRISES TWO OR THREE FIELDS. IN THE MEANTIME, THE DEGRADATION OF THE FLATNESS WAS APPROXIMATELY +/5 PERCENT AS STATED ABOVE. ACCORDINGLY, THE POSSIBILITY OF THE INJURY IS VERY LOW, AND NO INJURY HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864122 PROBEAT PROTON BEAM THERAPY SYSTEM LHN HITACHI,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown