BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    MDR report key: 22794883 · Received August 13, 2025

    Report

    Report Number
    8043933-2025-00058
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    May 29, 2025
    Report Date
    August 13, 2025
    Manufacturer
    BRAINLAB AG
    Product Code
    QIH
    PMA / PMN Number
    K243698
    Removal / Correction Number
    96241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: 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: IF THE PATIENT ID IS CHANGED VIA MERGE OR EDIT FUNCTION AND SUBSEQUENTLY ONLY THE GENDER OF THAT PATIENT RECORD IS CHANGED, OR, 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. H7: BRAINLAB IS IN THE PROCESS OF ISSUING FIELD SAFETY CORRECTIVE ACTION (FSCA) INFORMATION FOR THIS POTENTIAL SAFETY ISSUE TO ALL APPLICABLE REGULATORY AUTHORITIES. ON FEBRUARY 4TH, 2025, BRAINLAB ISSUED THE 21 CFR 806 REPORT OF CORRECTION TO THE FDA. THE DISTRIBUTION OF THE FIELD SAFETY NOTICE / PRODUCT NOTIFICATION TO AFFECTED CUSTOMERS HAS BEEN COMPLETED IN THE USA. BRAINLAB WILL PROVIDE A SOFTWARE REVISION OF THE ORIGIN DATA MANAGEMENT SOFTWARE WITH THE DESCRIBED ISSUE CORRECTED TO ALL AFFECTED CUSTOMERS. (B)(4). BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT A PATIENT RECORD DID NOT APPEAR IN THE BRAINLAB PATIENT SELECTION APPLICATION WHEN THE PATIENT'S NAME WAS SEARCHED. THE CUSTOMER FOUND THE MISSING PATIENT DATA MERGED INTO A DIFFERENT PATIENT RECORD AND WAS ABLE TO RESTORE THE PATIENT RECORDS TO THEIR ORIGINAL STATES. NO PATIENT WAS AFFECTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66226 ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT) Automated Radiological Image Processing Software QIH BRAINLAB AG 30074-04C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown