MalfunctionDSF
INFINITY R50N RECORDER
Received Dec 13, 2011 · Event occurred Nov 17, 2011
Report 1220063-2011-00078 · MDR key 2391967
Device
Generic name
Recorder
Manufacturer
Drager Medical Systems, Inc. (it/m)Model number
540068Catalog number
540068
Lot number
NA
Product problems
- Device Emits Odor
- Overheating of Device
- Smoking
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING TRAINING, AN INFINITY R50N RECORDER BEGAN TO HAVE A STRONG BURNING SMELL, SMOKE, AND WAS HOT TO THE TOUCH AFTER A FEW HOURS OF USAGE. THERE WAS NO PT INJURY REPORTED.
Additional Manufacturer Narrative
DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.