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)
Date of Event	07/02/2020
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 a vmat plan gave the wrong vmat rotation arc.
Additional Manufacturer Narrative
Section g3 date received by manufacturer added.Section h6 coding updated.Section h10/h11 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 maximum gantry angle on this machine is 180 degrees.The defect is the code that sets gantry angles in the optimizer does not use a tolerance so the result of adding the start angle with a given rotation arc should be equal to 180 degrees but due to floating point arithmetic it could be slightly over 180 degrees which causes the issue seen in this case.There was no mistreatment for the patient.The issue is detectable and can be avoided by the user's intervention.The defect will be fixed in a future release.

• 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: 10349038
• Report Number: 1937649-2020-00015
• Device Sequence Number: 16743870
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: 00858164002169
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MONACO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1