CLINITEK STATUS+
Received Jun 18, 2025 · Event occurred May 19, 2025
Report 3002637618-2025-00045 · MDR key 22282576
Device
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON INVESTIGATION, EVIDENCE OF VOLTAGE OVERLOAD ON THE MAIN BOARD WAS IDENTIFIED. SPECIFICALLY, THE D16 DIODE WAS DAMAGED. THE CAUSE OF D16 FAILURE WAS IDENTIFIED AS INCORRECT POWER SUPPLY CONFIGURATION WAS USED IN THE DEVICE. WHEN A D16 COMPONENT FAILS, THE CONTENTS ON THE INSIDE MAY APPEAR AS SMOKE.
Additional Manufacturer Narrative
SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND NOTED THAT THERE WERE NO ISSUES WITH THE POWER OUTLET. THE INSTRUMENT AND POWER SUPPLY WERE REQUESTED TO BE RETURNED AS WELL AS MORE INFORMATION FOR FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.
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.