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 Clinical Signs, Symptoms or Conditions (4582)
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 if a couch is removed while a plan is loaded, and then added back to the studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.A monaco unity plan can be calculated without including the couch attenuation.The dose distribution shown in monaco without the couch attenuation will not match the dose delivered to the patient when the couch is present.This issue happens when only a particular workflow is being used with monaco and elekta unity and not with elekta conventional linac.A field corrective action notice will be issued.An important field safety notice (ifsn 382-01-mon-019) will be issued.The defect will be fixed in a future release of monaco which is estimated to be released june 2022.
Event or Problem Description
A customer reported that the elekta unity couch became unassigned in the treatment aids tab for a reference plan.The customer was using version 5.40.01.(mfr report #: 1937649-2021-00001).During internal investigations it was ascertained that the issue also occurs in version 5.51.10, which is a different 510k number (k190178).

• 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: 12239189
• Report Number: 1937649-2021-00002
• Device Sequence Number: 3670401
• 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: K190178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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
• Device Model Number: Monaco
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1