CLINITEK ADVANTUS
Received Mar 25, 2026 · Event occurred Mar 11, 2026
Report 3002637618-2026-00023 · MDR key 24684374
Device
Product problems
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND NOTED THAT THE INSTRUMENT (B)(6) HAS EXCEEDED THE EXPECTED SERVICE LIFE OF THE CLINITEK ADVANTUS SYSTEM. THE CUSTOMER WAS USING THE DEVICE BEYOND ITS INTENDED USAGE LIFE. THE EVENT WAS DUE TO USER ERROR.
Additional Manufacturer Narrative
SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND NOTED THAT THERE WERE NO ISSUES WITH THE POWER OUTLET. THE AFFECTED MAIN PCB WAS 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 ADVANTUS DEVICE PRODUCED A SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.