BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    MDR report key: 24453186 · Received February 26, 2026

    Report

    Report Number
    8043933-2026-00011
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 12, 2026
    Report Date
    February 26, 2026
    Manufacturer
    BRAINLAB SE
    Product Code
    QIH
    PMA / PMN Number
    K243698
    Removal / Correction Number
    Z-1392-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: THIS IS RELATED TO THE DEVICE RECALL FOR BRAINLAB ORIGIN DATA MANAGEMENT (ODM) SOFTWARE VERSIONS 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 WITH THE RECALL NUMBER Z-1392-2025, AND THE RECALL EVENT ID 96241. DUE TO THIS ISSUE, FOR EXAMPLE, DATA FROM PATIENT A MAY BE AUTOMATICALLY AND INCORRECTLY MERGED INTO AN UNRELATED PATIENT B BY THE ODM SOFTWARE, WHICH LEADS TO: THE UNINTENDED DISPLAY OF DATA FROM PATIENT A IN PATIENT B. (BRAINLAB DATA SELECTION APPLICATION). THE UNINTENDED REMOVAL OF PATIENT_A FROM THE PATIENT LIST. (BRAINLAB PATIENT SELECTION APPLICATION). IF THE AUTOMATIC ERRONEOUS MERGING OF DATA FROM TWO UNRELATED PATIENT RECORDS IS NOT DETECTED BY THE USER IN THE SUBSEQUENT STEPS OF TREATMENT PREPARATION, AND DATA FROM PATIENT A IS USED TO MAKE CLINICAL DECISIONS FOR PATIENT B, THIS COULD, IN A WORST-CASE SCENARIO RESULT IN TREATMENT ERROR OR SERIOUS INJURY. AT THE TIME OF WRITING, THERE HAS BEEN NO REPORTED NEGATIVE CLINICAL EFFECT ON ANY PATIENT DUE TO THIS ISSUE. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE EFFECT OBSERVED WAS DUE TO A SYSTEMATIC ERROR FOR WHICH BRAINLAB HAS INITIATED ONGOING FIELD SAFETY CORRECTIVE ACTIONS: TWO SOFTWARE ANOMALIES IN BRAINLAB ORIGIN DATA MANAGEMENT (ODM) SOFTWARE VERSIONS 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1, THAT LEAD TO AUTOMATIC AND INCORRECT MERGES OF PATIENT RECORDS, WITHOUT ANY USER NOTIFICATION, UNDER SPECIFIC CIRCUMSTANCES. CIRCUMSTANCES IN WHICH THE ISSUE OCCURS: THE PROBLEM OCCURS IF SPECIFIC WORKFLOWS ARE APPLIED EITHER IN THE BRAINLAB PATIENT SELECTION APPLICATION, OR IN A HOSPITAL INFORMATION SYSTEM (HIS) THAT IS CONNECTED TO THE ABOVE-LISTED VERSIONS OF BRAINLAB ODM SOFTWARE: 1. IF THE PATIENT ID IS CHANGED VIA MERGE OR EDIT FUNCTION AND SUBSEQUENTLY ONLY THE GENDER OF THAT PATIENT RECORD IS CHANGED, OR, 2. IF THE PATIENT ID OF ONE PATIENT RECORD IS CHANGED FROM ITS ORIGINAL VALUE TO A NEW VALUE AND SUBSEQUENTLY, THIS ORIGINAL VALUE IS APPLIED (VIA MERGE OR EDIT FUNCTION) AS THE TARGET PATIENT ID OF ANOTHER PATIENT RECORD. THE INCORRECT MERGE OF PATIENT RECORDS THAT WAS DISCOVERED AT THIS USER FACILITY ORIGINATED FROM ONE OF THE AFFECTED VERSIONS OF ODM. H7: ON FEBRUARY 4TH, 2025, BRAINLAB ISSUED THE 21 CFR 806 REPORT OF CORRECTION REGARDING THIS ISSUE TO THE FDA. BRAINLAB IS CURRENTLY PROVIDING A SOFTWARE REVISION OF THE ORIGIN DATA MANAGEMENT SOFTWARE WITH THE DESCRIBED ISSUE CORRECTED TO ALL AFFECTED CUSTOMERS. FOR THIS CASE, BRAINLAB HAS ALREADY FOLLOWED UP WITH THE CUSTOMER REGARDING THE RESULTS OF THIS INVESTIGATION. AFTER THE DISCOVERED INCORRECT MERGE OF THE PATIENT RECORDS WAS CORRECTED, A REVIEW WAS PERFORMED TO IDENTIFY IF OTHER INCORRECTLY MERGED PATIENT RECORDS EXISTED IN THIS CUSTOMER'S SYSTEM. NONE WERE FOUND.

    Description of Event or Problem · 0

    WHILE SEARCHING FOR A MISSING PATIENT RECORD IN THE BRAINLAB PATIENT SELECTION 6.1 APPLICATION, A CUSTOMER DISCOVERED THAT THE MISSING PATIENT RECORD HAD BEEN MERGED WITH AN UNRELATED PATIENT RECORD. THE CUSTOMER RESTORED THE MERGED PATIENT RECORD TO ITS ORIGINAL CONSTITUENT PATIENT RECORDS ON THE SAME DAY. AFTER THIS, THE MISSING PATIENT RECORD BECAME AVAILABLE IN THE PATIENT LIST. ACCORDING TO THE HOSPITAL, NO PATIENT WAS AFFECTED DUE TO THE DESCRIBED ISSUE AS NEITHER OF THE PATIENTS HAS HAD TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350975 ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT) Automated Radiological Image Processing Software QIH BRAINLAB SE 30074-04C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown