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)
Date of Event	07/05/2018
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
(b)(6) is allowing the creation of multiple external contours resulting in the ssd (source-to-skin-distance) not being calculated correctly.
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.Monaco needs to have one structure of classification "external" in order to calculate treatment plans.Monaco allows duplicate structures with classification of external (i.E.External = patient outline), when an unusual configuration is used.This occurs when a user imports an anatomical group (i.E.Template with structure names/properties) into a patient that already has an external structure associated with it.When this happens, there could be graphical display issues such as the beam being erroneously presented (the central beam line) and the ssd (source to skin distance) could be incorrect which could lead to the dose reference points (point calculations used for qa comparisons) not being calculated, however the 3d dose calculation which is used by the user to evaluate the plan (dvh - dose volume histogram, isodose lines, mus) is still correct which is why this is not a safety issue that would lead to a mistreatment.

• Brand Name: MONACO
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC; 13723 riverport drive; suite 100; maryland heights MO 63043
• MDR Report Key: 7804497
• Report Number: 1937649-2018-00010
• Device Sequence Number: 1637638
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: 00858164002169
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1