MalfunctionMLD
CARDIOCAP 5
Received Mar 26, 2012 · Event occurred Mar 1, 2012
Report 9610105-2012-00014 · MDR key 2508516
Device
Generic name
Patient Monitor
Manufacturer
Ge HealthcareProduct problems
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE HOSPITAL STAFF SMELLED AND SAW SMOKE FROM THE CARDIOCAP 5 PATIENT MONITOR DURING PATIENT USE. THERE WAS NO REPORT OF FIRE OR FLAMES. THE CAUSE OF THE SMOKE HAS NOT BEEN IDENTIFIED. THE MONITOR WAS IMMEDIATELY REMOVED FROM USE. THERE WAS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. NOR WAS MEDICAL INTERVENTION REQUIRED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.