MalfunctionFAZ
CRYOTECH LCS
Received Jan 18, 1996 · Event occurred Dec 12, 1995
Report 1218402-1996-00005 · MDR key 29695
Device
Product problems
- Component(s), overheating of
- Electrical /Electronic Property Problem
- Device Emits Odor
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WHILE PREPARING FOR A CRYOSURGICAL PROCEDURE THE STAFF DETECTED A BURNING SMELL. THE SYSTEM WAS SHUT DOWN AND MOVED TO A ROOM WITH AN OUTSIDE VENT HOOD. UPON EXAMINATION IT WAS NOTED THE EXHAUST HEAT EXCHANGER HAD MELTED. NO PTS WERE IN THE ROOM AT THE TIME. THERE WAS NO KNOWN STAFF INJURY.