BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 3941760 · Received March 5, 2014

    Report

    Report Number
    2950347-2014-00008
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Report Date
    June 4, 2015
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH REVIEW OF THE INCIDENT FROM THE INFORMATION PROVIDED, AND EVALUATION OF THE PRODUCT. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. THIS DEFECT WAS FIXED IN THE LATER VERSION. (B)(4) WAS ISSUED, AND CORRECTION REPORT WAS SUBMITTED (REPORT NUMBER 2950347-051514-001-C, RECALL NUMBER Z-1800-2014). THE SEVERITY AND FREQUENCY (PROBABILITY) FOR THIS ISSUE WAS EVALUATED AS FOLLOWS: SEVERITY WOULD BE CRITICAL. PRESUPPOSING A QUALIFIED AND TRAINED MEDICAL PROFESSIONAL OPERATING ACCORDING TO STANDARD CLINICAL PRACTICE, IF THE ERROR WAS NOT DETECTED, IT COULD RESULT IN SERIOUS INJURY OR SERIOUS HEALTH CONSEQUENCES. IT IS POSSIBLE TO CHANGE THE DIRECTION(BEAM) AXIS, IN ANY DIMENSION, RESULTING IN A PATIENT SHIFT IN THE WRONG DIRECTION ALONG THAT AXIS. ALSO, IT IS POSSIBLE TO CHANGE THE SITE WHICH IN TURN WOULD CHANGE THE OFFSET VALUES RESULTING IN AN INCORRECT PATIENT SHIFT. THIS COULD RESULT IN A GEOMETRIC MISS OR TREATMENT OF THE INCORRECT AREA. TARGETS WOULD LIKELY BE UNDER DOSED AND NORMAL STRUCTURES OVERDOSED WITH A GEOMETRIC MISS. PROBABILITY IS REMOTE. IT IS IMPROBABLE THAT CRITICAL HARM WOULD OCCUR. THE DIRECTION OR SITE CHANGE COULD BE MISSED AND THE PATIENT TREATED INCORRECTLY FOR SOME FRACTIONS, BUT WHEN THE PATIENT IS IMAGED FOR TREATMENT FIELD VERIFICATION, THE ERROR SHOULD BE OBVIOUS AND WOULD BE DETECTED BY THE USER SO THAT SUBSEQUENT FRACTIONS COULD BE CORRECTED. HOWEVER, THE PROBABILITY WAS LEFT AT A "REMOTE" AND NOT BROUGHT LOWER BECAUSE THE IMPLICATION IN ONE OF THE REPORTED INCIDENTS WAS THAT PREVIOUS PATIENTS COULD HAVE BEEN MISTREATED AND THERE WAS NO INDICATION THAT THESE TREATMENT ERRORS WERE CAUGHT. THE CONCLUSION CODE WAS DETERMINED BASED ON THE INVESTIGATION RESULT AND THE CAUSE DETERMINED. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. THE PROBLEM OCCURS BECAUSE MOVEMENT OF THE MOUSE THUMBWHEEL OR TOUCHPAD SCROLL BAR IS CHANGING THE DIRECTION OR SITE OPTIONS WHEN IT SHOULD NOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER IF ABLE TO MODIFY THE CMA OFFSET VALUES ONCE THEY ARE SENT OVER FROM XVI WITHOUT ANY WARNINGS. THERE WAS NO MISTREATMENT REPORTED AS A RESULT OF THIS ISSUE BASED ON THE AVAILABLE INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DIRECTION OF THE SHIFTS IN THE COUCH MOVE ASSISTANT (CMA) WAS CHANGED WITHOUT MOSAIQ GENERATING ANY WARNING MESSAGES, RESULTED IN THE COUCH MOVING IN THE WRONG DIRECTION. THIS WAS REPLICATED BY JUST ROLLING THE MOUSE WHEEL UP OR DOWN ONCE THE CMA WINDOW WAS OPENED AS THE LATERAL COORDINATES DROP DOWN MENU (RIGHT/LEFT) WAS AUTOMATICALLY HIGHLIGHTED. THERE WAS NO ACTUAL MISTREATMENT AS THE ISSUE WAS CAUGHT BY THE RADIOGRAPHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131651 MOSAIQ MOSAIQ ONCOLOGY INFO SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1