MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INC. ARIA; ACCELERATOR, LINEAR, MEDICAL

Device Problems Computer Software Problem (1112); Loss of Data (2903)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

A software server space issue resulted in unrecorded delivered dose and failure to store pre-treatment images.The treatment data was recovered and restored for all patients.Image data was lost for all patients except those being treated on the varian true beam machine.Those patients whose images were lost were re-imaged.

• Brand Name: ARIA
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS INC.; 3100 hansen way; palo alto CA 94304
• MDR Report Key: 4067983
• MDR Text Key: 4738712
• Report Number: 4067983
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2014
• Patient Sequence Number: 1
• Treatment: BEING USED ON FOUR DIFFERENT RADIATION ONCOLOGY; H141002ARIA SERVER, SN (B)(4); AT SATELITE LOCATIONS: SN (B)(4); VARIAN TRUE BEAM, (B)(4) AND THREE MACHINES; (B)(4), (B)(4), (B)(4); NO OTHER DEVICES CONTRIBUTED. THE SOFTWARE WAS; MACHINES (MODEL AND SERIAL #): (B)(4), (B)(4)
• Patient Age: 6 YR