CLINITEK ADVANTUS
Received May 9, 2022 · Event occurred Feb 15, 2022
Report 3002637618-2022-00018 · MDR key 14337250
Device
Product problems
- Smoking
- Smoking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED THAT THE INSTRUMENT AND POWER SUPPLY BE RETURNED FOR FURTHER EVALUATION. ON MAY 3, 2022 SIEMENS WAS INFORMED THAT THE CUSTOMER SHIPPED THE INSTRUMENT TO THE INCORRECT ADDRESS AND IT CANNOT BE RETRIEVED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. THE CUSTOMER IS OPERATIONAL WITH A REPLACEMENT INSTRUMENT. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR CLINITEK ADVANTUS INSTRUMENT WAS SMOKING FROM THE PRINTER. THE CUSTOMER STATED THEY REPLACED THE PRINTER HEAD BUT THE INSTRUMENT WAS STILL SMOKING. SIEMENS REQUESTED THAT THE CUSTOMER IMMEDIATELY UNPLUG AND CEASE USE OF THE INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Remedial action
- Replace