MAUDE Adverse Event Report: IMPAC MEDICAL SYSTEMS, INC. MONACO RTP SYSTEM; RADIATION TREATMENT PLANNING SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that the patient was treated with bolus; however, the plan did not include bolus.This incident resulted in a dose difference that is presumed to result in serious injury.Patient's status is unknown.No further information was reported.

• Brand Name: MONACO RTP SYSTEM
• Type of Device: RADIATION TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): IMPAC MEDICAL SYSTEMS, INC.; 13723 riverport drive; suite 100; maryland heights MO 63043
• Manufacturer Contact: christopher ivicevich, director ; 100 mathilda place; 5th floor; sunnyvale, CA 94086 ; 4088308023
• MDR Report Key: 3631895
• MDR Text Key: 17388465
• Report Number: 1937649-2014-00001
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2014

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
• Device Operator: Health Professional
• Other Device ID Number: VERSION 3.20.00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other