BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 16111028 · Received January 6, 2023

    Report

    Report Number
    3015232217-2023-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    November 29, 2022
    Report Date
    June 6, 2023
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H10 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED AS ISSUE WITH MOSAIQ NOT RECORDING THE DELIVERED DOSAGE (MUS - MONITOR UNITS) THAT THE PATIENT RECEIVED DURING TREATMENT. INVESTIGATION OF THE MOSAIQ LOGS FOUND THAT IN A TREATMENT PLAN THAT WAS DELIVERED WITH COMPOSITE FIELD SEQUENCING, A NETWORK ERROR OCCURRED (AFTER THE FIRST TWO FIELDS WERE DELIVERED), ON A MOVE ONLY SEGMENT, CAUSING A COMMUNICATION ERROR BETWEEN THE CITRIX SERVER AND SEQUENCER. THE NETWORK ERROR RESULTED IN ALL DELIVERED MONITOR UNITS BEING INCORRECTLY RECORDED FOR THE FIRST FIELD AND ZERO MONITOR UNITS BEING RECORDED FOR THE SECOND FIELD (RECORDING ISSUE). THE USER RECEIVED A WARNING THAT MORE MONITOR UNITS (MUS) THAN EXPECTED WERE DELIVERED TO THE FIRST FIELD. IN ADDITION, A SECOND WARNING WAS PRESENTED INFORMING THE USER THAT A NETWORK ERROR HAD OCCURRED AND ANY TREATMENT RECORDINGS SHOULD BE VERIFIED. THE USER WOULD ALSO RECEIVE DOSE WARNINGS AS WELL WHEN SELECTING TO TREAT THE SECOND FIELD AND THE REMAINDER OF THE FIELDS IN THE SESSION. DESPITE THE WARNINGS PRESENTED BY MOSAIQ THE USER, RE-SELECTED THE DOSAGE FOR THE FIELD THAT HAD RECORDED ZERO MONITOR UNITS. BASED UPON THE INFORMATION AVAILABLE THIS ADDITIONAL DOSAGE TO THE PATIENT HAS BEEN ASSESSED BY ELEKTA PHYSICS AS INSIGNIFICANT. THE ROOT CAUSE FOR THIS ISSUE WAS DETERMINED TO BE USE ERROR.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH MUS NOT BEING RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512950 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB MOSAIQ 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown