BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 7637076 · Received June 26, 2018

    Report

    Report Number
    2950347-2018-00015
    Event Type
    Injury
    Date Received
    June 26, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ELEKTA INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. MOSAIQ IS WORKING AS DESIGNED AND INTENDED. THE USER DELETED THE DOSIMETRY ON TWO FIELDS AND SUBSEQUENTLY DELIVERED TWO EXTRA TREATMENTS. THIS WAS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FIELDS WERE UNLINKED FROM THE PRESCRIPTION AND THE PATIENT WAS TREATED TO MORE FRACTIONS THAN PRESCRIBED. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481743 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1