MalfunctionMLD
CARDIOCAP 5
Received Oct 9, 2012 · Event occurred Sep 11, 2012
Report 9610105-2012-00038 · MDR key 2785162
Device
Generic name
Multi-parameter Patient Monitor
Manufacturer
Ge Healthcare Finland OyProduct problems
- Device Emits Odor
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE CARDIOCAP 5 WAS IN USE MONITORING A PT WHEN VISIBLE SMOKE BEGAN COMING FROM THE UNIT AND A STRONG SMOKE ODOR WAS PRESENT IN THE ROOM. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.