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 Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	01/20/2020
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 the structure display has flipped in monaco in the tsc views.
Additional Manufacturer Narrative
D4.Serial number and unique identifier (udi) number corrected.G5.Pma/510(k) number corrected.H10.Additional information.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 it is possible to end up with a contour in the wrong position when the user renames a structure to a structure name that is already defined for the patient.Renaming a structure to an existing structure name can only occur when the new structure name does not have any contours assigned to it.When the renaming is performed, monaco copies the contour information in it's memory from the old structure name to the new structure.During this renaming process, a defect can occur causing the contours to be rotated and flipped after they are copied to the new structure name.The issue will be fixed in a future release of monaco® software.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
• MDR Report Key: 9726927
• Report Number: 1937649-2020-00001
• Device Sequence Number: 2041136
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: 00858164002169
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1