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

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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 using a specific workflow it is possible that the forced electron density could be turned off unintentionally.
Event or Problem Description
During elekta internal investigations an adapt anatomy layering and density problem was found.
Additional Manufacturer Narrative
B1 updated.D3 updated information.H6 updated.H10 updated: 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.Workflow: · the force ed flag not set internally in 5.51 · create an external structure using the auto-margin tool.For example, body (currently designated as type = external) + immobilization device.· change the type of the external auto-margin structure to external.· external structure is automatically set to force ed on the adapt setup tab.· uncheck force ed on mr for structure body on the adapt setup tab.· adapt anatomy to another image set.· problem - force ed is not checked for the external structure.Using the specific workflow described above, it is possible that the forced electron density will be turned off unintentionally.In this case, mr pixel data are applied which can result in an incorrect dose calculation.Structure densities can be up to 14.9 times higher than they should be.This could result in an overdose to the patient which could exceed 5%.However, 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: 8900401
• Report Number: 1937649-2019-00012
• Device Sequence Number: 2048150
• Product Code: MUJ
• UDI-Device Identifier: 00858164002268
• UDI-Public: 00858164002268
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1