inforMED
MalfunctionJIL

CLINITEK STATUS+

Received May 10, 2023 · Event occurred Apr 14, 2023

Report 3002637618-2023-00025 · MDR key 16901692

Device

Generic name

Clinitek Status+

Catalog number

10379675

Product problems

  • Smoking
  • Smoking

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE CUSTOMER STATED THAT THEY DISPOSED OF THE INSTRUMENT. THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE. THE CAUSE OF THIS EVENT IS UNKNOWN.

Description of Event or Problem

THE CUSTOMER STATED THAT SMOKE WAS SEEN COMING OUT FROM RIGHT SIDE OF THE INSTRUMENT WHEN IT WAS PLUGGED IN. NO FLAMES WERE SEEN. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

Additional Manufacturer Narrative

SIEMENS HAS REQUESTED MORE INFORMATION FOR FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.