BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 16688271 · Received April 6, 2023

    Report

    Report Number
    3015232217-2023-00015
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 8, 2023
    Report Date
    July 17, 2023
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002336
    PMA / PMN Number
    K183034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT DURING TREATMENT THERE WAS A BEAM TIMER ERROR. THE BMDM (BEAM MU DOSE/DISPLAY MODULE) WAS RESET AND THE MODALITY BECAME UNKNOWN. IT WAS ASCERTAINED FROM THE MOSAIQ LOG FILES THAT THE TREATMENT DELIVERY WAS INTERRUPTED BY BEAM TIMER ERRORS. AT THIS POINT 458.2 MUS OF THE PRESCRIBED 687.7 MUS WAS DELIVERED. THE CUSTOMER INFORMED THAT THE USER RESET THE BMDM, AS THEY WANTED TO RESUME TREATMENT, BUT THE ACTUAL MODALITY WAS NOT REGISTERING. THE REMAINING MUS WERE DELIVERED AT THE END OF THE DAY (LAST FRACTION) AND THERE WAS NO MISTREATMENT. THE CAUSE OF WHY THE ACTUAL VALUE WAS DISPLAYED AS 'NONE' FOR MODALITY ON THE MACHINE (AND SHOWED AS 'UNKNOWN' IN MOSAIQ AS A RESULTS OF THIS) WHILST THE PRESCRIBED VALUES WERE SET CANNOT BE ESTABLISHED DUE TO THE SDD LOGS NO LONGER BEING AVAILABLE FOR INVESTIGATION FROM THE CUSTOMER SITE. THE CUSTOMER HAS BEEN ADVISED TO RETAIN THE SDD LOGS AND PROVIDE THEM TO ELEKTA IF THIS ERROR REOCCURS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING TREATMENT THERE WAS A BEAM TIMER ERROR. THE BMDM WAS RESET AND THE MODALITY BECAME UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798292 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB MOSAIQ 00858164002336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown