CLINITEK STATUS+
Received Dec 1, 2025 · Event occurred Nov 4, 2025
Report 3002637618-2025-00080 · MDR key 23682365
Device
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER RETURNED THEIR INSTRUMENT FOR INVESTIGATION HOWEVER, THE POWER SUPPLY AND BATTERIES WERE NOT PROVIDED. THE INVESTIGATION CONCLUDED THAT THE SMOKING THE CUSTOMER SAW WAS DUE TO A FAILURE OF THE D16 DIODE WHICH FAILS WHEN IT IS EXPOSED TO OVERVOLTAGE. THE CUSTOMER STATED THAT WHEN THE INCIDENT OCCURRED, THEY IMMEDIATELY REMOVED THE BATTERIES AND DISCONNECTED THE INSTRUMENT FROM THE CLINITEK STATUS CONNECT SYSTEM. PER THE CONNECT SYSTEM OPERATOR¿S GUIDE, ¿YOU CANNOT OPERATE THE INSTRUMENT ON BATTERY POWER WHEN USING THE CONNECTOR.¿ THE CAUSE OF THIS EVENT WAS DUE TO USER ERROR.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED THAT THE INSTRUMENT AS WELL AS ANY BATTERIES AND/OR POWER SUPPLY IN USE AT THE TIME OF THE EVENT BE RETURNED FOR FURTHER INVESTIGATION. INVESTIGATION WILL COMMENCE ONCE THE INSTRUMENT HAS BEEN RECEIVED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THEIR CLINITEK STATUS+ DEVICE WAS SMOKING. THE DEVICE LOST CONNECTIVITY TO THE NETWORK AND STARTED SMOKING. THERE WAS NO VISIBLE FIRE. THE CUSTOMER REMOVED THE BATTERIES AND DISCONNECTED THE DEVICE FROM THE BASE. THE CUSTOMER TRIED POWERING ON THE DEVICE, BUT IT WAS UNSUCCESSFUL. THERE IS NO REPORT OF HARM DUE TO THIS EVENT.