CLINITEK STATUS+
Received Aug 5, 2020 · Event occurred Jul 23, 2020
Report 3002637618-2020-00040 · MDR key 10367220
Device
Product problems
- Smoking
- Smoking
Patient
Not reported
- No Patient Involvement
- No Clinical Signs, Symptoms or Conditions
- No Patient Involvement
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER HAS BEEN ADVISED NOT TO USE THE CONNECT BASE AND A REPLACEMENT HAS BEEN SENT. SIEMENS HAS REQUESTED THAT THE CUSTOMER RETURN THE INSTRUMENT FOR INVESTIGATION, HOWEVER IT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR CONNECT PLATFORM GAVE OFF A SMALL PUFF OF SMOKE AND NO LONGER POWERS ON THE INSTRUMENT. THE INSTRUMENT POWERS ON WITH NO ISSUES WHEN CONNECTED DIRECTLY TO THE POWER SUPPLY. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED THE INSTRUMENT FOR FURTHER INVESTIGATION. THE CLINITEK STATUS+ WAS FUNCTIONING BUT THE CONNECT BASE WAS DAMAGED DUE TO FAILURE OF T1 COMPONENT. INVESTIGATION REVEALED THAT A COMPONENT MANUFACTURING ISSUE WITH CHOKE T1 WAS IDENTIFIED AND FIXED THROUGH AN ENGINEERING CHANGE NOTICE IN 2009. THE FAILURE OF THESE CHOKES DOES NOT POSE A SAFETY RISK AS THE PLASTICS MAKING UP THE CONNECT BASE ARE 94V0. THE CUSTOMER WAS SENT A REPLACEMENT CONNECT BASE, AND THEY ARE OPERATIONAL.
Remedial action
- Replace