ALIGNRT
Received Nov 19, 2015 · Event occurred Oct 21, 2015
Report 3004832819-2015-00001 · MDR key 5249571
Device
Generic name
Patient Positioning System
Manufacturer
Vision Rt LimitedModel number
ALIGNRTCatalog number
ALIGNRT
Lot number
NA
Product problems
- Device Displays Incorrect Message
- Positioning Problem
Patient
NK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION OF THE ISSUE IS STILL IN PROGRESS.
Description of Event or Problem
THERE ARE NO REPORTS OF ANY PATIENT OR USER HARM RELATED TO THIS ISSUE. ALIGNRT (AND GATERT) CAN BE INTERFACED TO GATE THE TREATMENT BEAM ON SIEMENS LINACS. WHILST CONNECTED TO A SIEMENS LINAC, FOR REASONS STILL UNDER INVESTIGATION THE ALIGNRT SYSTEM MAY REPORT THE FOLLOWING WARNING MESSAGE DURING A PERIOD OF BEAM-HOLDING DUE TO THE PATIENT BEING OUT OF POSITION: "LINAC BEAM STATUS IS NOT AS SET. HOLD THE BEAM FROM THE LINAC CONSOLE. GATING HAS BEEN DISABLED. RESTART ALIGNRT TO ENABLE GATING". WHILE THE WARNING MESSAGE IS DISPLAYED AND FROM THIS POINT ONWARDS, THE ALIGNRT SYSTEM MAY ALLOW THE BEAM ON THE LINAC TO BE ENABLED INDEPENDENTLY OF THE PATIENT POSITION. THIS OCCURRED ONLY AT ONE CUSTOMER'S SITE. THE CUSTOMER CONFIRMED THAT THE ISSUE WAS PROMPTLY IDENTIFIED AND THAT NO PATIENT HARM OCCURRED. THERE ARE NO REPORTS OF A SIMILAR ISSUE HAVING OCCURRED AT OTHER SITES.