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	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that monaco transfers a value for the bolus description to mosaiq even if there is no bolus defined.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
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 which did not remove the bolus information during the dicom export routine from monaco to mosaiq.This issue is detectable during the fundamental qa process by the user.On reviewing the plan before treatment the dosimetrist will verify the plan to ensure that there is no discrepancy and then a medical physicist will double check the plan.A third check is performed by a therapist before the patient is treated.This is a global requirement and fundamental qa process.All plans must be validated for correctness, including a secondary monitor unit (mu) check, by qualified personnel before clinical use.A secondary mu check would include a bolus factor.This review would detect a discrepancy between monaco and mosaiq for consistency between the plan data in monaco and the data received by mosaiq.If the fundamental qa process is dismissed by the user, this indicates a level of malpractice that will result in the patient being underdosed as the dose that the patient was treated with would not reflect the dose displayed in monaco.Elekta assessed the severity of risk to be "insignificant" and probability to be "incredible" if this were to occur.The risk assessment concluded that the defect was within the "acceptable" region.For this case as part of the initial review, the customer performed the routine physics chart check, the bolus was detected and the patient was not mistreated.The issue has been fixed in monaco 6.00.01 for use with conventional linacs and will be fixed in a future release for use with elekta unity.

• 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
• Manufacturer (Section G): ELEKTA INC.; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 12719417
• Report Number: 1937649-2021-00007
• Device Sequence Number: 14450978
• Product Code: MUJ
• UDI-Device Identifier: 00858164002268
• UDI-Public: 00858164002268
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown