MAUDE Adverse Event Report: VARIAN ARIA EMR

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

Varian medica systems aria emr displays incorrect information about the delivery of radiation therapy.Error occurs when a routine event occurs that momentarily interrupts treatment.The gantry angle and field size is then reported to have been different than the planned position without any other warning.The actual treatment was delivered accurately.

• Brand Name: ARIA EMR
• Type of Device: ARIA
• Manufacturer (Section D): VARIAN
• MDR Report Key: 3805751
• MDR Text Key: 4387918
• Report Number: MW5036008
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other