MalfunctionMLD
CARDIOCAP 5
Received Jun 16, 2017 · Event occurred May 19, 2017
Report 9610105-2017-00041 · MDR key 6647391
Device
Generic name
Monitor, St Segment With Alarm
Manufacturer
Ge Healthcare Finland OyProduct problems
- Smoking
- Smoking
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DATE OF DEVICE MANUFACTURE IS NOT AVAILABLE. GE HEALTHCARE'S ENGINEERING TEAM HAS CONFIRMED THE ISSUE LIES IN A COMPONENT (FET V8) FAILURE OF THE DEVICE POWER SUPPLY DUE TO WEAR OUT. THERE IS NO RISK OF FIRE RELATED TO THIS ISSUE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem
IT WAS REPORTED THE DEVICE EMITTED SMOKE WHEN IT WAS POWERED ON BY THE USER. THE DEVICE WAS NOT CONNECTED TO A PATIENT WHEN THE ISSUE OCCURRED.