CLINITEK STATUS+
Received Feb 17, 2026 · Event occurred Jan 23, 2026
Report 3002637618-2026-00009 · MDR key 24368453
Device
Product problems
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER RETURNED THEIR STATUS+ INSTRUMENT AS WELL AS THE ORIGINAL POWER SUPPLY FOR INVESTIGATION. THE CUSTOMER STATED THEY USED THE POWER SUPPLY AND NO BATTERIES. THE RETURNED UNIT WAS OPENED, AND A SHORT-CIRCUIT TEST WAS PERFORMED USING DIGITAL MULTIMETER. A DAMAGED TVS DIODE (D16) WAS IDENTIFIED AS THE LIKELY POINT OF FAILURE. THE BURNT ODOR IS ATTRIBUTED TO OVERHEATING OF THE DIODE DUE TO REPEATED AND CONTINUOUS CLAMPING OF VOLTAGES EXCEEDING ITS THRESHOLD. THIS CONDITION CAN RESULT FROM POWER FLUCTUATIONS THAT CAUSE SUDDEN VOLTAGE TRANSIENTS ON THE STATUS DEVICE POWER INPUT. THERE IS NO FIRE RISK AS THE DIODE (D16) FAILS SAFELY UNDER TRANSIENT OVERVOLTAGE CONDITIONS, WITH ONLY BRIEF LOCALIZED HEATING AND NO SUSTAINED CURRENT, ARCING, OR IGNITION. THE CAUSE OF THE OVERVOLTAGE IS UNKNOWN.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED THE INSTRUMENT AND POWER SUPPLY IN USE AT THE TIME OF THE EVENT TO BE RETURNED FOR INVESTIGATION. INVESTIGATION WILL COMMENCE ONCE MATERIALS HAVE BEEN RECIEVED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THERE WAS VISIBLE SMOKE FROM THEIR CLINITEK STATUS+ INSTRUMENT. THE CUSTOMER STATED THAT THEY WERE USING THE POWER CORD THAT COMES WITH THE SYSTEM AND BATTERIES WERE NOT INSTALLED. A REPLACEMENT INSTRUMENT HAS BEEN SENT TO THE CUSTOMER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.