RPM RESPIRATORY GATING SYSTEM
Received Oct 5, 2011 · Event occurred Sep 5, 2011
Report 2916710-2011-00131 · MDR key 2291600
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
THE CUSTOMER REPORTS THAT WHILE EVALUATING THE ALIGNRT SYS (VISIONRT) WITH RPM, THEY FOUND A DEVIATION WHEN PRODUCING A BREATHING MOTION FOR THE PHANTOM AND MONITORING THE RPM AMPLITUDE WITH VISIONRT ON AND OFF. THE PHANTOM (A POLYSTYRENE MANNEQUIN) WAS SET UP AND THE GATING BOX PLACED THE BASE OF THE STERNUM, THE TILT OF THE BOX WAS NO MORE THAN 10 DEGREES FROM THE CAMERA PLANE. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS EVENT.