CLINITEK STATUS+
Received Sep 2, 2025 · Event occurred Aug 4, 2025
Report 3002637618-2025-00067 · MDR key 22931576
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, DAMAGED POWER CORD WAS IDENTIFIED. THE DEVICE WAS FUNCTIONING WHEN TESTED WITH ANOTHER POWER CORD. THE CAUSE OF POWER CORD DAMAGE IS UNKNOWN.
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.