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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going, and further information will be provided once the investigation has completed.Establishment name updated.Email and address updated.Resubmitting form 3500a due to an administrative error.It was requested by fda medwatch program department to re-submit the initial report as there was no record of initial report submission in emdr system.
Event or Problem Description
The customer reported that a patient was mistreated with version (b)(4) before the upgrade to 5.10.04.In (b)(6).

• Brand Name: MONACO
• Common Device Name: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC.; 1450 beale street; suite 205; st. charles MO 63303
• Manufacturer (Section G): ELEKTA INC.; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 6939520
• Report Number: 1937649-2017-00001
• Device Sequence Number: 3204050
• Product Code: MUJ
• UDI-Device Identifier: 00858164002152
• UDI-Public: 00858164002152
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K151233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: Monaco
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 10/11/2017
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown