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 Underdose (2166)
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 could not be reproduced with data and information the customer has provided and it was not possible to determine if a malfunction occurred with the product.Investigation into potential workflow causes have been exhausted.Based on the information available a mistreatment occurred to a patient.The dose discrepancy for this particular patient was negligible as was determined by (b)(4) and corroborated by the customer site.If this same problem were to occur whilst treating another patient, it could go undetected and the dose difference could be larger potentially resulting in serious injury.
Event or Problem Description
The customer reported that the plan exported from (b)(4) differs to what is being displayed by isodoses and dose volume histogram (dvh).

• 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: 7624623
• Report Number: 1937649-2018-00009
• Device Sequence Number: 16692798
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: (01)00858164002169(10)5.11.02
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physicist
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 05/25/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1