BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS BRAND NAME

    MDR report key: 2012773 · Received March 2, 2011

    Report

    Report Number
    2910081-2011-00008
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL). THE WRONG TABLE OFFSET MAY BE APPROVED AND THEN APPLIED FOR SEVERAL FRACTIONS. THIS MAY CAUSE A DOSE TO WRONG LOCATION AND THUS MAY POTENTIALLY RESULT IN A SERIOUS INJURY. PROBABILITY: D (OCCASIONALLY). THE ISSUE MAY HAPPEN DURING AN ALLOWED WORKFLOW. THERE IS A CHANCE, THAT THE USER RECOGNIZE THE WRONG OFFSET AND TAKE CORRECTIVE ACTIONS, BUT IT MAY ALSO OCCUR, THAT THE USER DOES NOT RECOGNIZE THE DEVIATION. THERE ARE CURRENTLY ONLY FEW CONFIGURATIONS INSTALLED, THAT COULD USE INCREMENTAL LOADING. NO OTHER PRODUCTS ARE AFFECTED. ROOT CAUSE: WHEN INCREMENTAL LOADING TRIGGERS WHOLE PATIENT LOAD, DUE TO SOFTWARE ERROR THERE ARE DUPLICATE ENTRY FOR IMAGE CREATED IN DATA MODEL (FROM ONE OF THE INTERMEDIATE IMAGES IN THE VERSION CHAIN). APPLICATION LOADS THIS INTERMEDIATE IMAGE INSTEAD OF THE LATEST ONE AND INCORRECT OFFSET IS SHOWN. A FINAL CORRECTIVE ACTION DECISION AND SUBSEQUENT ACTION IS PENDING FURTHER INVESTIGATION. THIS EVENT IS NOT ASSOCIATED WITH ANY SPECIFIC DEVICE.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN IDENTIFIED INTERNALLY DURING TESTING WITH OUR ARTISTE ACCELERATOR AND ITS ASSOCIATED COMPONENT RTT SYNGO SOFTWARE. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. THERE HAS BEEN NO MISTREATMENT, INJURY OR ADVERSE EVENT REPORTED. WHEN USING INCREMENTAL LOADING OF PATIENT DATA IT MAY OCCUR THAT INCORRECT PATIENT OFFSETS ARE SHOWN (APPLIED) AFTER INCREMENTAL LOADING OF PATIENT. THIS ISSUE HAS BEEN FOUND TO BE REPRODUCIBLE. WHEN A PATIENT HAS AT LEAST ONE OLD SESSION IN THE DATABASE AND WHEN A SUBSEQUENT DELIVERY IS TRIGGERED, THE PREVIOUS SESSIONS MAY NOT BE LOADED INTO THE DATABASE. AS A RESULT THERE IS A POTENTIAL FOR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS BRAND NAME ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1