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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
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 beams with mu calculated are showing 0% weight in the prescription tab.
Additional Manufacturer Narrative
B3 updated.G4 updated.H6 corrected.H10 corrected: the investigation was completed by conducting a thorough evaluation of the product and the reported information.With the information provided by the customer if the weight for selected beams is set to zero and the isodose display shows that these zero weight beams are not a contributing dose.However, the monitor units for these zero weight beams are not deleted and are dicom exported.If the mu is delivered for these beams, the dose delivered would be greater than the isodose display indicates.Elekta have been unable to reproduce this issue.The prescription page would show an inconsistency between the beam weight of zero and the monitor units displayed for the beam.The dose reference point page would show a beam dose of zero that is inconsistent with the non-zero monitor units of the beam.Qa checks completed by the user would detect the issue.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: 9981769
• Report Number: 1937649-2020-00008
• Device Sequence Number: 4356176
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: 00858164002169
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151233
• 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): 06/24/2020

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: 03/23/2020
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1