OPTIMA NX
Received Nov 11, 2005 · Event occurred Oct 5, 2005
Report 2126677-2005-00032 · MDR key 646011
Device
Generic name
Nuclear Medicine
Manufacturer
Ge Medical Systems, LlcModel number
9SYS0088-DCatalog number
NA
Lot number
NA
Product problems
- Difficult To Position
Patient
3 MO
- Physical Entrapment
- Fracture, Arm
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHEN SETTING UP A OPTIMA NX SYSTEM FOR A TOMOGRAPHIC SCAN, THE OPERATOR ROTATED THE GANTRY TO THE TOMO START POSITION RESULTING IN THE DETECTOR HEAD COLLIDING WITH THE PT ARM. THE PT SUFFERED A BROKEN ARM. A STATIC SCAN OF THE PT USING THE SAME SYSTEM HAD JUST BEEN COMPLETED PRIOR TO THIS INCIDENT. THE OPERATOR ACKNOWLEDGED A USER INTERFACE PROMPT TO AUTOMATICALLY MOVE THE CAMERA FROM THE STATIC SCAN TO THE TOMO START POSITION. THE PT WAS NOT APPROPRIATELY POSITIONED FOR THE COMMANDED MOTION. THE PT'S ARM WAS CAUGHT BETWEEN A STRETCHER AND ONE OF THE CAMERA'S DETECTOR HEADS WHEN THE CAMERA REPOSITIONED. ALTHOUGH THE SYSTEM USES A CLUTCH MECHANISM TO MINIMIZE THE FORCE APPLIED BY THE DETECTOR IN THE EVENT OF COLLISION, THIS INJURY STILL OCCURRED.
Remedial action
- Inspection