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	Radiation Overdose (1510); No Information (3190)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was determined to be a defect in the product.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 incorrect mu's calculation.
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 incorrect mu's calculation.Actual mistreatment to patient could result in serious injury.

• 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: 8678446
• Report Number: 1937649-2019-00007
• Device Sequence Number: 13957469
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: (01)00858164002169(10)5.11.02
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Followup
• Report Date (Section B): 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other