BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 12598120 · Received October 8, 2021

    Report

    Report Number
    3015232217-2021-00002
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 9, 2021
    Report Date
    December 20, 2021
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    MUJ
    UDI-DI
    00858164002275
    PMA / PMN Number
    K202789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H7 UPDATED. H10 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE USE OF INCORRECT MACHINE MODEL FILES WITH MONACO. A PLAN CREATED IN A VERSION PRIOR TO 6.0 CAN BE CALCULATED WITH COUCH ANGLES OTHER THAN ZERO. AFTER MONACO IS UPGRADED TO A VERSION 6.0 OR GREATER, AND THE PLAN IS RECALLED, THE COUCH ANGLES WILL BE INCORRECTLY SET TO ZERO AND CANNOT BE EDITED TO NON-ZERO VALUES. FOR THE PROBLEM TO OCCUR, CERTAIN MONACO TREATMENT MACHINE MODEL FILES MUST HAVE SPECIFIC PROPERTIES. IT IS POSSIBLE TO EXPORT A MONACO PLAN WITH BEAM COUCH ANGLES INCORRECTLY SET TO ZERO, BUT THE MONACO DOSE DISTRIBUTION REFLECTS A CALCULATION PERFORMED WITH NON-ZERO COUCH ANGLES. THE DOSE DISTRIBUTION IN MONACO WILL NOT REFLECT THE DOSE DELIVERED TO THE PATIENT. IRRADIATED AREAS OF THE PATIENT COULD BE OVERDOSED OR UNDERDOSED. ELEKTA ASSESSED THE SEVERITY OF RISK TO BE SERIOUS. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT. AN IMPORTANT FIELD SAFETY NOTICE (382-01-MON-021) WAS SENT TO ONE AFFECTED CUSTOMER ON (B)(6) 2021 (ELEKTA REFERENCE #: (B)(4). IT WAS ASCERTAINED THAT ONLY ONE CUSTOMER HAS INCORRECT MACHINE MODEL FILES WITH MONACO 6.X). MONACO 6.X COUCH LIMIT VALIDATION LOGIC DOES NOT PROPERLY HANDLE NON-STANDARD MACHINE MODEL FILES. THE ISSUE DESCRIBED ABOVE DID NOT AFFECT ANY CUSTOMERS DEVICES IN THE UNITED STATES OF AMERICA AND ONLY AFFECTED ONE CUSTOMER DEVICE WORLDWIDE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY CANNOT USE NON-COPLANAR ARCS/BEAMS WITH VERSA HD AND/OR AGILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496538 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ ELEKTA SOLUTIONS AB MONACO 00858164002275

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown