MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MONACO; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Lot Number	6.1.4
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the wrong dose is associated with (b)(6).
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H11.Updated: the customer reported that the wrong dose is associated with ptv3600mp.An investigation was attempted by conducting an evaluation of the product and the reported information.Attempts were made to reproduce the issue using internal test systems, but no issue was found.The customer has also been unable to reproduce the issue.The software code has been inspected and tested, with no logic error identified.Therefore, because the issue could not be reproduced it was not possible to determine if a malfunction occurred with the product.Monaco displayed that there was a wrong dose distribution, alerting the user that there was a problem.This issue was identified before clinical use during the planning phase.Based on the available information there was no patient mistreatment.

• Brand Name: MONACO
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 21771682
• Report Number: 3015232217-2025-00005
• Device Sequence Number: 8200227
• Product Code: MUJ
• UDI-Device Identifier: 07340201500033
• UDI-Public: (01)07340201500033(10)6.1.4.0
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K213787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 6.1.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown