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	07/19/2019
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 when using two specific workflows it is possible that the forced electron density could be turned off unintentionally.
Event or Problem Description
The customer reported an adapt to shape (ats) layering and density problem.Based upon the available information there has been no actual mistreatment.
Additional Manufacturer Narrative
The investigation found that monaco® is calculating incorrect electron density (ed) information in specific situations.The dose calculation is also affected.It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.A field corrective action notice (fca-ims-0033) and was reported to the regulatory authorities on 4 september 2019.An important field safety notice (382-01-mon-015) was sent to all affected customers on 4 september 2019 which provides a work around to avoid the issue.A software patch to correct the issue is estimated to be released october 2019.

• Brand Name: MONACO
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC; 13723 riverport drive; suite 100; maryland heights MO 63043
• MDR Report Key: 8900392
• Report Number: 1937649-2019-00011
• Device Sequence Number: 290625
• Product Code: MUJ
• UDI-Device Identifier: 00858164002190
• UDI-Public: (01)00858164002190(10)5.40.00
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K183037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1