BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 8093870 · Received November 21, 2018

    Report

    Report Number
    2950347-2018-00040
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    September 18, 2018
    Report Date
    April 17, 2019
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT-PATIENT INFORMATION UPDATED. H10 UPDATED: THE INVESTIGATION FOUND IF THERE ARE NO WEDGE IDS INCLUDED IN THE DICOM RT PLAN SENT FROM THE TPS THE FIELD IN MOSAIQ WILL BE CREATED WITH NO WEDGE. MOSAIQ IS DEPENDENT ON THE PRESENCE OF THE WEDGE ID TO ASSIGN A WEDGE TO A BEAM AT THE TIME OF PLAN PROMOTION, REGARDLESS OF THE PRESENCE OF OTHER WEDGE INDICATORS (E.G. NUMBER OF WEDGES OR WEDGE POSITION). NO WARNINGS ARE PRESENTED IF WEDGE IDS ARE NOT PRESENT. IF NOT DISCOVERED, IT IS POSSIBLE THAT FIELDS PLANNED WITH WEDGES CAN BE DELIVERED WITHOUT THE WEDGE. TREATMENT OF A FIELD WITHOUT THE PLANNED WEDGE WILL RECEIVE MORE DOSE THAN THE TREATMENT PLAN INDICATES. THE ROOT CAUSE WAS THAT THE WEDGE LABEL WAS NOT DEFINED IN DICOM PLAN, THEREFORE MOSAIQ DOES NOT IMPORT WEDGE INFORMATION AT ALL. A RECALL HAS BEEN RELEASED AS THE CORRECTIVE ACTION FOR THE DEFECT IDENTIFIED IN MOSAIQ. FCA-IMS-0027 WAS NOTIFIED TO THE AUTHORITIES ON (B)(6)2018. AN IFSN 371-01-MSQ-013 WAS RELEASED TO ALL AFFECTED CUSTOMER SITES ON 13 DECEMBER 2018. THREE PATCHES HAVE BEEN RELEASED FOR IMPLEMENTATION IN THE FIELD AS FOLLOWS: IFSM 371-02-MSQ-013 RELEASED DATE (B)(6)2019 - MOSAIQ VERSION 2.64.278 (SP11) IFSM 371-02-MSQ-014 RELEASED DATE (B)(6)2019 - MOSAIQ VERSION 2.70.89 IFSM 371-02-MSQ-015 RELEASED DATE (B)(6)2019 - MOSAIQ VERSION 2.65.249 (SP2) A FURTHER PATCH WILL BE RELEASED FOR MOSAIQ VERSIONS LOWER THAN 2.64 WHICH IS ESTIMATED JUNE 2019.

    Description of Event or Problem · 0

    A THIRD PARTY SUPPLIER TO A CUSTOMER REPORTED THAT THE WEDGE FIELDS WERE TREATED AS OPEN FIELDS. BASED ON THE AVAILABLE INFORMATION MISTREATMENT TO A PATIENT COULD POTENTIALLY RESULT IN SERIOUS CLINICAL OUTCOME. ELEKTA PHYSICS ASSESSED THAT THE PATIENT RECEIVED A DAILY OVER DOSE OF ~23% AND ~23% OVER THE COURSE OF THE TREATMENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT.

    Description of Event or Problem · 1

    A THIRD PARTY SUPPLIER TO A CUSTOMER REPORTED THAT THE WEDGE FIELDS WERE TREATED AS OPEN FIELDS. BASED ON THE AVAILABLE INFORMATION MISTREATMENT TO A PATIENT COULD POTENTIALLY RESULT IN SERIOUS CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933396 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other