NM MILLENNIUM MPR COLLIMATOR
Received Dec 30, 2004 · Event occurred Nov 29, 2004
Report 9613299-2004-00010 · MDR key 563044
Device
Generic name
Collimator
Manufacturer
Ge Medical Systems, F.i. HaifaModel number
NICatalog number
NA
Lot number
NA
Product problems
- Use of Device Problem
Patient
NO INFO
- Bone Fracture(s)
Narrative
Description of Event or Problem
A REPORT WAS RECEIVED CONCERNING A PT NOSE INJURY IN MPR SYSTEM. THE EVENT OCCURRED IN PREPARATION FOR THYROID SCAN WITH LEGP COLLIMATOR. THE USER LOWERED THE DETECTOR HEAD AT NORMAL SPEED, USING THE HAND HELD CONTROLLER WHILE PT WAS LYING ON BED. WITHOUT BEING NOTICED BY THE OPERATOR, THE DETECTOR CAME IN CONTACT TO THE PT NOSE. THE GANTRY MOVEMENT WAS STOPPED UPON PSD ACTIVATION, BUT THE PT NOSE WAS DAMAGED; POTENTIALLY BROKEN. THE SCAN WAS STOPPED AND NO FURTHER SCANS WERE MADE TO THE PT. SYSTEM WAS RECHECKED BY FILED ENGINEERING FOR NORMAL SPD OPERATION (STOP MOTION UPON SLIGHT CONTACT BY THE OPERATOR). THE SYSTEM BEHAVED NORMALLY AND WAS RETURNED TO NORMAL USE ROUTINES FOR THE SAME TYPE OF SCANS WITH OTHER PTS.