MAUDE Adverse Event Report: CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA MONACO; SYSTEM,PLANNING,RADIATION THERAPY TREATMENT

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that mlc port edits using leaf table do not invalidate dose.This happens even if the calculation point is blocked by leaf positions.There was no mistreatment.This issue was found internally.

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.This defect will be fixed in a later version.

• Brand Name: MONACO
• Type of Device: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section G): CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA; impac medical systems, inc.; 13723 riverport drive; maryland heights MO 63043
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 4786928
• MDR Text Key: 5855315
• Report Number: 1937649-2015-00010
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: VERSION 5.10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1