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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that the issue was determined to be a defect with the product.Monitor units can be incorrect when following a specific workflow in monaco®.When creating 3d plans using either mu or dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the monitor units are scaled incorrectly.A field corrective action notice (fca-ims-0031) was notified to the regulatory authorities on 4 july 2019.An important field safety notice (382-01-mon-013) was sent to all affected customers on 3 july 2019.The notice informs users of the specific product and version numbers affected by the issue.It also provides a work around to avoid the issue.A software patch to correct the issue is estimated to be released december 2019.
Event or Problem Description
The customer reported mu calculation wrong in 3d plan.Based on available information there was no mistreatment.

• 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: 8797354
• Report Number: 1937649-2019-00008
• Device Sequence Number: 11540605
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: (01)00858164002169(10)5.11.02
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151233
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1