MalfunctionLEL
SOMNO TRAC (OMEGA)
Received Mar 9, 1999 · Event occurred Feb 16, 1999
Report 2050001-1999-00036 · MDR key 213578
Device
Generic name
Sleep Disorder Testing System
Manufacturer
Sensormedics Corp.Model number
4250Catalog number
771990
Lot number
*
Product problems
- Thermal Decomposition of Device
- Smoking
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WHILE CONDUCTING AN ANALYSIS OF A SLEEPING PT, IT WAS REPORTED THAT THE AMPSTAR HEADBOX WAS SMOKING AND WIRES WERE BURNING. THERE WERE NO INJURIES TO ANYONE.