CLINITEK STATUS+
Received Jun 27, 2025 · Event occurred May 30, 2025
Report 3002637618-2025-00049 · MDR key 22343301
Device
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED THEIR SYSTEM TO SIEMENS FOR PHYSICAL INSPECTION AND INVESTIGATION. AN INVESTIGATION WAS CONDUCTED ON THE RETURNED DEVICE. AS PART OF THE INVESTIGATION, VISUAL INSPECTION AND AUTOMATED DIAGNOSTIC TESTS WERE PERFORMED. NO BURNING SMELL WAS OBSERVED FROM THE DEVICE. THE SOURCE OF THE SMOKE COULD NOT BE DETERMINED. INSTRUMENT IS OPERATING AS INTENDED.