BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C4D SOFTWARE

    MDR report key: 10384419 · Received August 10, 2020

    Report

    Report Number
    3006621300-2020-00002
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 10, 2020
    Manufacturer
    C-RAD POSITIONING AB
    Product Code
    IYE
    PMA / PMN Number
    K113276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN IMMEDIATE ACTION THE AFFECTED USERS ARE RECOMMENDED TO: AVOID SELECTING FIELDS WHILE IN THE SETUP WORKFLOW STEP, ALL OTHER WORKFLOW STEPS ARE OK. VERIFY THE LOADED SITE AT THE PRE-SETUP WORKFLOW STEP. IF NOT CORRECT, RELOAD THE SELECTED FIELD IN THE LINAC. VERIFY THE ACTIVE POSITION REFERENCE AT THE SETUP WORKFLOW STEP. IF BEING THE POSITION REFERENCE OF AN INCORRECTLY LOADED SITE, ENTER PRE-SETUP AND RELOAD THE SELECTED FIELD IN THE LINAC. VERIFY THE CURRENT LOADED FIELD AT THE SETUP WORKFLOW STEP. IF THE FIELD INFORMATION IS MISSING, ENTER PRE-SETUP AND RELOAD THE SELECTED FIELD IN THE LINAC.

    Description of Event or Problem · 1

    IF A FIELD IS SELECTED AT THE LINAC, C4D WILL AUTOMATICALLY LOAD THE CORRESPONDING FIELD WHEN CONFIGURED FOR TREATMENT FIELD PATIENT SYNCHRONIZATION (E.G. ELEKTA ICOM OR VARIAN ADI INTERFACES). WHEN A FIELD OF A NEW SITE IS SELECTED, C4D WILL AUTOMATICALLY ENTER THE PRE-SETUP WORKFLOW STEP. WHEN AT THE SETUP WORKFLOW STEP AND SELECTING A FIELD OF ANOTHER SITE FOR THE CURRENT PATIENT, AN ISSUE HAS BEEN IDENTIFIED WHERE C4D ENTER PRE-SETUP WITH THE CURRENT SITE REMAINING INCORRECTLY LOADED, NOT CHANGING TO THE SITE OF THE SELECTED FIELD. IF THE USER THEN CONTINUES TO SETUP, THE PATIENT CAN BE POSITIONED ACCORDING TO THE POSITION REFERENCE OF THE INCORRECTLY LOADED SITE, WHICH MAY RESULT IN A PATIENT MISALIGNMENT RELATIVE TO THE CURRENT FIELD LOADED IN THE LINAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851124 C4D SOFTWARE SOFTWARE FOR RADIOTHERAPY POSITIONING SYSTEM IYE C-RAD POSITIONING AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other