CLINITEK STATUS+
Received Aug 26, 2024 · Event occurred Aug 9, 2024
Report 3002637618-2024-00088 · MDR key 20065225
Device
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CUSTOMER'S ISSUE WAS EVALUATED, AND THE DEVICE WAS REQUESTED FOR INVESTIGATION. SIEMENS HAS SHOWN ITS DUE DILIGENCE IN ATTEMPTING TO OBTAIN TO THE STATUS+ FROM THE CUSTOMER, BUT THE CUSTOMER HAS NOT RESPONDED. WITHOUT THE RETURNED DEVICE, FURTHER INVESTIGATION CANNOT BE COMPLETED. IT IS RECOMMENDED THAT THE APPROPRIATE POWER SOURCE IS USED, OR TO USE A POWER CONDITIONER TO PREVENT UNINTERRUPTED POWER OR POWER SURGES. THE CAUSE OF THE EVENT IS UNKNOWN. NO PRODUCT PROBLEM HAS BEEN IDENTIFIED.
Description of Event or Problem
THE CUSTOMER STATED THAT THERE WAS VISIBLE SMOKE COMING FROM THEIR CLINITEK STATUS+. NO FLAMES WERE SEEN. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED THE INSTRUMENT AND POWER SUPPLY TO BE RETURNED AS WELL AS MORE INFORMATION FOR FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.