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

Model Number	MONACO
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that a plan was made in monaco 5.51.0 with 33 fields of square size 10x10, all having 100 mu and the same isocenter.An interest point was placed in the isocenter where the individual beam dose distribution can be read.The system did not take into account the last three fields (beam 31, 32 and 33) and did not update the dose volume histogram for these beams.There was no patient involvement, it was a phantom patient.
Additional Manufacturer Narrative
H10 additional information.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.The customer had created a 3d test plan for a phantom patient with 33 beams.On reviewing the plan based on the dose displayed it could be seen that 3 beams towards the bottom of the phantom were not showing any dose.If beams are turned off when the final 3 beams are reached they have no effect on the display.The prescription tab showed that the beams had a weight of 0%.If the plan was to be exported and the mu delivered, the dose delivered would not match the dose displayed in monaco.Elekta tried to reproduce the issue with the customer's phantom patient plan, however the calculation was satisfactory and the final 3 beams showed dose and mus correctly.The customer's plan used a dose calculation grid of 0.3 mm and a statistical uncertainty of 0.1% per control point.As this is not a clinical plan a statistical uncertainty would only be used for test purposes on a 1 beam plan.The customer increased their statistical uncertainty to a clinical 1% per plan and the error no longer occurred.The customer has since upgraded to monaco 5.51.02 and again the issue can no longer be reproduced at 0.1% statistical uncertainty per control point.Elekta were unable to reproduce the issue and are therefore unable to determine a root cause for the problem.The dose display and dvh clearly showed the user that the beams had not been calculated so this should have been detectable.

• Brand Name: MONACO
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC; 1450 beale street; suite 205; st. charles, mo
• MDR Report Key: 10078453
• Report Number: 1937649-2020-00010
• Device Sequence Number: 11725506
• Product Code: MUJ
• UDI-Device Identifier: 00858164002268
• UDI-Public: 00858164002268
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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 Model Number: MONACO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1