MalfunctionJIL
CLINITEK STATUS+
Received May 5, 2026 · Event occurred Apr 6, 2026
Report 3002637618-2026-00053 · MDR key 25076728
Device
Product problems
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE STATUS+ DEVICE PRODUCED A SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS SHOWN DUE DILIGENCE IN ATTEMPTING TO HAVE THE CUSTOMER RETURN THE INSTRUMENT FOR INVESTIGATION. HOWEVER, THE CUSTOMER WAS UNABLE TO RETURN THE PRODUCT FOR FURTHER INVESTIGATION. WITHOUT THE INSTRUMENT, NO INVESTIGATION CAN BE PERFORMED. THE CAUSE OF THIS EVENT IS UNKNOWN.