BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 5906006 · Received August 26, 2016

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    2950347-2016-00042
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Report Date
    March 31, 2017
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE ENERGY ON BEAMS 1 AND 2 WAS PLANNED FOR 10MV BUT TREATED AS 6MV. MOSAIQ MALFUNCTIONED WHEN A PREVIOUSLY RECORDED AD HOC ORPHANED PORTAL FIELD WAS SELECTED TO SEND TO THE MACHINE AND FAILED. THE INVESTIGATION FOUND THAT WHEN THE NEXT PLAN IN MOSAIQ IS THEN SELECTED FOR TREATMENT, MOSAIQ READS THE ENERGY FOR THE FAILED PORTAL FIELD AND APPLIES IT TO THE TREATMENT FIELDS FOR THE SELECTED PLAN. IF THE DISCREPANCY BETWEEN MOSAIQ AND THE MACHINE IS NOT NOTICED BY THE USER (PLAN STYLE MACHINE INTERFACE), THE PATIENT MAY BE TREATED WITH THE WRONG ENERGY BEAM. THE USER'S WORKFLOW IS VERY UNUSUAL. THE MOSAIQ USER GUIDE EXPLAINS THAT SENDING A VARIAN AD HOC FIELD BACK TO THE TREATMENT MACHINE IS NOT SUPPORTED. THE ORPHANED FIELD IS NOT ASSOCIATED WITH ANY SITE AND THE USER HAS TO FORCE THIS ASSOCIATION MANUALLY. WHEN THE PLAN IS THEN SENT TO MOSAIQ, AN ERROR OCCURS WHICH SHOULD ALERT THE USER TO THE FACT THAT THE WORKFLOW IS PROBLEMATIC. FINALLY, QA CHECKS COMPARING THE ORIGINAL PLAN TO MOSAIQ WILL SHOW THAT THE ENERGY FOR SOME BEAMS HAS CHANGED. PRODUCT PROBLEM UPDATE. REPORTABLE EVENT UPDATE. ADDITIONAL MANUFACTURE NARRATIVE UPDATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, ON A TRUEBEAM DEVICE WITH MOSAIQ, TWO OF A PATIENT'S TREATMENTS WERE ADMINISTERED AT A LOWER ENERGY LEVEL THAN PLANNED. THE MISTREATMENT DID NOT RESULT IN SERIOUS INJURY FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561027 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1