BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 11975199 · Received June 10, 2021

    Report

    Report Number
    2950347-2021-00008
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 11, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    UDI-DI
    00858164002282
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED A RECORDING DISCREPANCY IN MOSAIQ. IT WAS ASCERTAINED FROM THE SOFTWARE LOGS THAT MOSAIQ CORRECTLY RECORDED THE MU VALUES SENT FROM THE LINAC, AND THE TOTAL DAILY DOSE OF ALL THE TREATMENT FIELDS ADDS UP TO THE EXPECTED TOTAL DAILY DOSE OF 1800 CGY. MOSAIQ IS WORKING AS DESIGNED AND INTENDED AND BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A RECORDING DISCREPANCY IN MOSAIQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869831 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC MOSAIQ 00858164002282

    Patients

    Seq Age Sex Outcome Treatment
    1