BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 16111027 · Received January 6, 2023

    Report

    Report Number
    3015232217-2023-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 5, 2022
    Report Date
    February 10, 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

    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 THE MACHINE WAS SET FOR THE PATIENT TO RECEIVE A TOTAL PRESCRIPTION OF 612 MUS FORMED OF SIX FIELDS. THE TREATMENT WAS INHIBITED SAFELY DUE TO A "VMI" ERROR AFTER 299 MUS OF THE 612 MUS THAT WERE GIVEN TO THE PATIENT. AT THIS POINT THREE OF THE FIELDS HAD BEEN FULLY TREATED AS PRESCRIBED (101, 102 AND 103). THE MACHINE FAULT AFFECTED HOW THE 299 MUS WAS PROCESSED FOR RECORDING. ALL 229 MUS WERE RECORDED TO ONLY ONE OF THE FIELDS (101) AND NOT TO THE THREE FIELDS. THIS PROMPTED THE 'MONITOR UNITS DELIVERED IS GREATER THAN THE MU PRESCRIBED' MESSAGE TO BE DISPLAYED. THE 299 MUS SHOULD HAVE BEEN ALLOCATED TO REFLECT THAT FIELD 101 WAS FULLY TREATED WITH 128.8 MU, FIELD 102 WAS FULLY TREATED WITH 88.0 MU, AND FIELD 103 WAS FULLY TREATED WITH 82.2 MU. WHEN THIS ISSUE OCCURS, IT IS OBVIOUS TO THE USER THAT THE TREATMENT WAS NOT RECORDED (OR RECORDED INCORRECTLY). WITH THE DATA FROM THE MACHINE LOG, THE USER (WITH HELP FROM OUR PRODUCT SUPPORT) WOULD BE ABLE TO VERIFY THE ACTUAL TREATMENT AND THE USER COULD RECORD MANUALLY WHAT WAS TREATED OR CORRECT ANY INCOMPLETE/INCORRECT TREATMENT. THIS ISSUE WOULD NOT LEAD TO SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT. MOSAIQ WORKED AS DESIGNED AND INTENDED.

    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
    512949 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB MOSAIQ 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown