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

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Radiation Overdose (1510)
Date of Event	04/27/2016
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 and had been previously identified and resolved.An important field safety notice (ifsn 382-01-mon-005) was issued to all customers with devices within scope, which included 5.10.02 which is the version the customer was running at the time of this incident occurred.This customer had received and installed the corrected version, 5.11 in june of 2016, however, that was after the patient had been treated before the ifsn was sent out.
Event or Problem Description
The customer reported that they have two patients presenting radiation damage from one and half years ago.Based upon the available information the patient received a dose of radiation that has led to 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: 7171513
• Report Number: 1937649-2018-00002
• Device Sequence Number: 1448112
• Product Code: MUJ
• UDI-Device Identifier: 00858164002152
• UDI-Public: 00858164002152
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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
• Type of Report: Initial
• Report Date (Section B): 01/08/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/08/2018
• 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