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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 investigation found that when importing a template, if the last beam in the template is an ssd beam, the user is given an opportunity to set the isocenter on the "new plan template" page.However, monaco does not recognize that the beams are ssd so the isocenter is not correctly set until selecting "ok' to leave the page.At that time, the isocenter for each ssd beam is corrected except the last beam in the plan.The last beam retains the incorrect isocenter set on the new plan template page.The result is that the actual beam is closer to the patient than it should be, and dose will be delivered outside of the region calculated by monaco.Qa checks completed by the user would catch these errors during beam qa.If the treatment is total body irradiation (tbi), extra qa and plan specific measurements are completed for these unique treatments which would detect errors.No patients were mistreated.This defect will be fixed in the next release of monaco.
Event or Problem Description
The customer reported that monaco tbi sse 350cm plan template shows a strange isodose line.

• Brand Name: MONACO
• Common Device Name: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC.; 1450 beale street; suite 205; st. charles MO 63303
• MDR Report Key: 10507472
• Report Number: 1937649-2020-00016
• Device Sequence Number: 11521288
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: 00858164002169
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: No Information
• Device Model Number: Monaco
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1