inforMED
MalfunctionJIL

CLINITEK STATUS+

Received Aug 26, 2024 · Event occurred Aug 9, 2024

Report 3002637618-2024-00088 · MDR key 20065225

Device

Generic name

Clinitek Status+

Catalog number

10379675

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.