MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT

Model Number 1060000

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

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

In previous sw versions, the last recorded couch position represented the position of the couch before treatment started.In radixact 2.X, the introduction of multiple delivery segments changed the meaning of the last recorded couch position to include any additional couch offsets applied during treatment.The shifts applied after the start of treatment will proportionally impact the effect on dose calculation; the offsets are expected to be in the range of 5mm.Visualizations of incorrect dose will be seen in preciseart but there is a hazard of overdose/underdose that could occur if the user decided to replan the patient and tried to compensate for the differences when replanning.A fix is being investigated.

Event Description

The preciseart software is used in conjunction with the radixact 2.X software and it was found that adaptive process was using actual registration offsets as opposed to the accepted offsets based on motion tracking move in y values.

Manufacturer Narrative

The initial report was provided based upon a preliminary analysis of the anomaly and associated risk.Upon further investigation by accuray, the anomaly was determined that it does not significantly impact dose accuracy and does not represent a serious risk to patients.

Event Description

Follow-up report.

• Brand Name: RADIXACT
• Type of Device: RADIXACT
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• MDR Report Key: 9545225
• MDR Text Key: 198742558
• Report Number: 3003873069-2019-00013
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K182687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1060000
• Device Catalogue Number: 1060000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1