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

Model Number	MONACO
Medical Device Problem Codes	Computer Software Problem (1112); Non Reproducible Results (4029)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that monaco 6.00.01 sends the incorrect number of fractions in dicom rtplan.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that monaco 6.00.01 sends the incorrect number of fractions in dicom treatment plan.The customer conveyed that they have software in place that detects differences between the number of fractions in the dicom treatment plan and the prescription.The customer has not informed elekta of any actual mistreatments.Based on the data and information provided, elekta have been unable to reproduce the problem experienced by the customer.There is no evidence or claim that the daily dose would be incorrect or that the individual fractions would be delivered incorrectly.The planning, scheduling, delivery and recording of the patient's daily treatments are performed independently of the dicom treatment plan in the "record and verify" system.This part of the treatment delivery workflow would be carried out according to the physician's actual intent.In the context of the larger workflow, the number of fractions within the dicom plan is a piece of dependent information that must be reconciled with the content of the "record and verify" system rather than the primary source of truth.The daily and total plan doses actually delivered to the patient would be expected to be correct and there is no risk of mistreatment to the patient.

• Brand Name: MONACO
• Common Device Name: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30345
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 16041266
• Report Number: 3015232217-2021-00022
• Device Sequence Number: 4896558
• Product Code: MUJ
• UDI-Device Identifier: 00858164002275
• UDI-Public: 00858164002275
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K202789
• 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): 02/27/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MONACO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 02/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown