BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C4D SOFTWARE

    MDR report key: 9834353 · Received March 16, 2020

    Report

    Report Number
    3006621300-2020-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 16, 2020
    Manufacturer
    C-RAD POSITIONING AB
    Product Code
    IYE
    UDI-DI
    07350005280024
    PMA / PMN Number
    K113276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTIFICATION TO CUSTOMERS: CUSTOMERS MUST MAKE SURE THAT AN INITIATED SAVE REFERENCE OPERATION IN C4D IS FULLY COMPLETED BEFORE THE LINAC TREATMENT MANAGEMENT SYSTEM OPERATOR SELECTS A NEW FIELD.

    Description of Event or Problem · 1

    IN PRESETUP-SETTINGS STATE THE USER IS ABLE TO CROP THE VOLUME OF INTEREST FOR THE CPOSITION REFERENCE TO DESIRED SIZE. THE USER NEEDS TO PRESS SAVE IN ORDER FOR THE NEW CROPPED CPOSITION REFERENCE TO BECOME ACTIVE. IF SAVE IS NOT PRESSED THERE WILL BE NO CHANGE TO THE CPOSITION REFERENCE. WHEN SAVE IS PRESSED A USER DIALOGUE IS PRESENTED "THE EDITED REFERENCE WILL BECOME THE ACTIVE REFERENCE. DO YOU WANT TO CONTINUE YES/NO?" UPON CONFIRMING WITH A YES, THE REFERENCE IS SAVED. IF A NEW FIELD IS SELECTED AT THE LINAC, C4D WILL AUTOMATICALLY ENTER THE PRESETUP STATE AND SHOW THE PRESETUP SCREEN. THE POTENTIAL ISSUE IS IF A NEW FIELD FOR THE SAME PATIENT IS SELECTED WHEN THE USER WAS EDITING A REFERENCE AND PRESSED SAVE BUT DID NOT ACKNOWLEDGE THE CONFIRMATION DIALOGUE. IF THE USER THEN CONFIRMS THE SAVE REFERENCE OPERATION AFTER THE NEW FIELD WAS SELECTED, C4D WILL ASSIGN THE REFERENCE TO THE SITE WHICH THE NEW FIELDS BELONGS TO IF THE PATIENT IS THE SAME. THIS IS AN ISSUE IF THE NEW FIELD BELONGS TO ANOTHER SITE THAN THE FIRST ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298190 C4D SOFTWARE SOFTWARE FOR RADIOTHERAPY POSITIONING SYSTEM IYE C-RAD POSITIONING AB CATALYST N/A 07350005280024

    Patients

    Seq Age Sex Outcome Treatment
    1