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)
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.It was ascertained that if a beam fails to calculate, the dose contribution for that one beam is removed from the overall dose calculation, however, the monitor units are not removed.The exported plan will still contain segments and mu for that beam.If the beam is delivered as exported, the plan dose distribution will not match the delivery.On the beam visibility tab, the uncalculated beam is unchecked and greyed out and the log file will also indicate a dose calculation failure for this beam.No patients were mistreated.This defect will be fixed in a future release.
Event or Problem Description
The customer reported a failure of dose distribution in qa mode of monaco.

• 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: 10276949
• Report Number: 1937649-2020-00014
• Device Sequence Number: 19093952
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: 00858164002169
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183037
• 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
• Report Date (Section B): 07/15/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1