MAUDE Adverse Event Report: ELEKTA INC. MONACO; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was determined to be a defect in the product.The customer has been informed of a workaround.Monaco is reporting the beam and anatomy shifts incorrectly (the table shifts are correct) in both the monaco scan and setup reference report and the monaco dicom plan export.Therefore, the shifts in all three directions (post/ant, sup/inf and left/right) can be in the opposite direction from where they should be.This could result in a geometric miss of which the probability has been assessed as "remote".
Event or Problem Description
The customer reported that monaco 5.51 pilot: anatomy vs beam offset references.There has been no actual mistreatment.
Additional Manufacturer Narrative
The investigation found that the issue was determined to be a defect with the product.Monaco® is displaying some incorrect shift information on the scan and setup reference report and is dicom exporting incorrect shift information.Monaco® is displaying the anatomy and beam shift direction incorrectly on the monaco® scan and setup reference report and dicom is exporting incorrect (anatomy/beam) shift directions.Therefore, the (anatomy/beam) shifts in all three directions (post/ant, sup/inf and left/right) can be in the opposite direction from what was intended.The table top shift directions (operator face to gantry), are described in the monaco® scan and setup reference report, are correct.All shifts should be verified before treatment by image guidance to verify isocenter location being standardized practice before first treatment.A field corrective action notice (fca-ims-0032) was notified to the regulatory authorities on 21 august 2019.An important field safety notice (382-01-mon-014) was sent to all affected customers on 23 august 2019 which provides a work around to avoid the issue.A software patch to correct the issue is estimated to be released september 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: 8849981
• Report Number: 1937649-2019-00010
• Device Sequence Number: 13517927
• Product Code: MUJ
• UDI-Device Identifier: 00858164002268
• UDI-Public: 00858164002268
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/02/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1