MalfunctionLEL
P-SERIES
Received Oct 6, 2004 · Event occurred Sep 27, 2004
Report 9613619-2004-00002 · MDR key 547549
Device
Generic name
Sleep Monitoring System
Manufacturer
Compumedics LimitedModel number
7001-0002-00Catalog number
7001-0002-00
Lot number
*
Product problems
- Use of Device Problem
Patient
NO INFO
- Burn, Thermal
Narrative
Description of Event or Problem
CUSTOMER CALLED AND REPORTED THAT WHEN THE PT RETURNED THE UNIT THEY INFORMED THE TECHNICIAN THAT THE FINGER PROBE (NONIN PROBE OXIMETER) BURNED THEIR FINGER.
Remedial action
- Replace