MalfunctionMLD
CARDIOCAP 5
Received Jun 12, 2014
Report 9610105-2014-00013 · MDR key 3955488
Device
Generic name
Monitor, St Segment With Alarm
Manufacturer
Ge Healthcare, Finland OyProduct problems
- Failure to Power Up
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE UNIT CANNOT BE SWITCHED ON AND SMOKE WAS COMING OUT OF THE HOUSING. IT WAS NOT REPORTED WHETHER A PATIENT WAS CONNECTED TO THE MONITOR AT THE TIME.
Additional Manufacturer Narrative
PATIENT DATA NOT CURRENTLY AVAILABLE. INCIDENT UNK AT THIS TIME. MANUFACTURE DATE IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.