MalfunctionMLD
CARDIOCAP 5
Received Feb 17, 2015 · Event occurred Jan 21, 2015
Report 9610105-2015-00004 · MDR key 4520706
Device
Generic name
Monitor, St Segment With Alarm
Manufacturer
Ge Healthcare Finland OyProduct problems
- Device Emits Odor
- Smoking
Patient
5 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A BURNING SMELL AND BLACK SMOKE EMITTING FROM THE DEVICE. NO PATIENT COMPROMISE.
Additional Manufacturer Narrative
MANUFACTURE DATE UNKNOWN AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative
INVESTIGATION REVEALED THE RECEIVED FAULTY SMOKING PART WAS A CC5 POWER SUPPLY MANUFACTURED IN 2001. THE COMPONENTS NEAR FET V8 WERE FOUND TO BE BURNED. THE ROOT CAUSE IS A WEAR OUT PHENOMENA. THE CC5 MONITOR POWER SUPPLY WAS REPLACED.