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)
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 on the monaco beam spreadsheet, it is possible to set the field size for a beam to symmetric (for a 3d plan) when the beam model identifies the machine jaws as asymmetric.The dicom export will read the beam spreadsheet value (symmetric in this case).The importing system could set the asymmetric beams to symmetric based on this information.The incorrect field would be treated which could result in an overdose or underdose of the ptv and subsequent overdose or underdose of normal structures.Dose errors could be greater than 5%.The probability of this occurring is implausible.Qa checks by the user and clinical qa would be verifying that the fields planned/calculated on monaco were correctly transferred to mosaiq.The field sizes switching from asymmetric on monaco to symmetric in mosaiq would be obvious and should be noticed by the dosimetrist, physicist and radiation therapist.The defect in monaco will be fixed in a future release.No patients were mistreated.
Event or Problem Description
The customer reported a monaco dicom export error.

• 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: 8674726
• Report Number: 1937649-2019-00006
• Device Sequence Number: 2349938
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: (01)00858164002169(10)5.11.02
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: 05/08/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1