MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB 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)
Date of Event	09/09/2021
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 they cannot use non-coplanar arcs/beams with versa hd and/or agility.
Additional Manufacturer Narrative
H6 updated.H7 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be use of incorrect machine model files with monaco.A plan created in a version prior to 6.0 can be calculated with couch angles other than zero.After monaco is upgraded to a version 6.0 or greater, and the plan is recalled, the couch angles will be incorrectly set to zero and cannot be edited to non-zero values.For the problem to occur, certain monaco treatment machine model files must have specific properties.It is possible to export a monaco plan with beam couch angles incorrectly set to zero, but the monaco dose distribution reflects a calculation performed with non-zero couch angles.The dose distribution in monaco will not reflect the dose delivered to the patient.Irradiated areas of the patient could be overdosed or underdosed.Elekta assessed the severity of risk to be serious.Based on the available information there has been no mistreatment.An important field safety notice (382-01-mon-021) was sent to one affected customer on (b)(6) 2021 (elekta reference #: (b)(4).It was ascertained that only one customer has incorrect machine model files with monaco 6.X).Monaco 6.X couch limit validation logic does not properly handle non-standard machine model files.The issue described above did not affect any customers devices in the united states of america and only affected one customer device worldwide.

• Brand Name: MONACO
• Common Device Name: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30345
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 12598120
• Report Number: 3015232217-2021-00002
• Device Sequence Number: 17153411
• Product Code: MUJ
• UDI-Device Identifier: 00858164002275
• UDI-Public: 00858164002275
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K202789
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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
• Device Model Number: MONACO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 12/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown