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 Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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 monaco calculated wrongly the mu.
Additional Manufacturer Narrative
H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The investigation found that the customer compared the monaco calculation result with the mu from radcalc (radcalc dose and mu check), which showed a difference in mu values.The customer then recalculated the same plan (without any change) on monaco, the original mu value disappeared and monaco displayed another mu value.Elekta contacted the customer who were unable to provide a detailed workflow of the issue.Elekta attempted to simulate the issue with the limited information provided in order to reproduce the issue.(b)(6) and the customer have been unable to reproduce the difference in mu values.The customer has not experienced this issue since and no patients were mistreated.

• 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: 9374881
• Report Number: 1937649-2019-00016
• Device Sequence Number: 19372925
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: 00858164002169
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 11/10/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: Monaco
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1