BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 7132916 · Received December 20, 2017

    Report

    Report Number
    2950347-2017-00033
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Report Date
    March 16, 2018
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    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 CUSTOMER HAS ALREADY MADE THE NECESSARY WORKFLOW ADJUSTMENTS BASED ON THE SOFTWARE FUNCTIONALITY. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO MISTREATMENT IN THIS CASE.

    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 THAT A PATIENT WAS SET UP ON THE CT IN 2 DIFFERENT POSITIONS: HEAD FIRST SUPINE TO TREAT SHOULDER; FEET FIRST SUPINE TO TREAT FEMUR. PATIENT DETAILS WERE SENT FROM PROSOMA (A THIRD PARTY TREATMENT PLANNING SYSTEM) TO MOSAIQ AND PATIENT POSITION WAS DISPLAYED CORRECTLY ON PROSOMA DOCUMENTATION. THE CUSTOMER EXPERIENCED PATIENT ORIENTATION BEING INCORRECTLY DISPLAYED IN SITE SET UP AND SITE SET UP BEING CORRECT BUT EDITABLE WHEN IT SHOULD BE LOCKED. BASED ON THE AVAILABLE INFORMATION, THERE HAVE BEEN NO ACTUAL MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915119 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1