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

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 incorrect monitor units for monaco 3d plan.Based on the available information there have been no actual mistreatment.
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.If the error was not detected it could result in serious injury or serious adverse health consequences.When using mu weighting mode, if the user changes the physician's intent prescription dose first and then the number of fractions, the mu is scaled incorrectly.If the monitor units are not correct, the patient will be incorrectly treated.This could be an overdose or underdose and could be in excess of 5%.It was improbable that critical harm would occur.The functionality described in this defect was implemented in release 5.0 and the customer has now upgraded to version 5.11.02.The customer has also stated that no patient mistreatment's have occurred as the potential would be picked up during the planning workflow.

• Brand Name: MONACO
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC; 400 perimeter center terrace; suite 50; atlanta GA 30346
• MDR Report Key: 7185203
• Report Number: 1937649-2018-00004
• Device Sequence Number: 19308604
• Product Code: MUJ
• UDI-Device Identifier: 00858164002152
• UDI-Public: 00858164002152
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: Physicist
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1