inforMED
MalfunctionJIL

CLINITEK STATUS+

Received Jul 21, 2022 · Event occurred Jul 12, 2022

Report 3002637618-2022-00048 · MDR key 15079181

Device

Generic name

Clinitek Status+

Model number

10379675

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

SIEMENS HAS ASKED FOR THE INSTRUMENT TO BE RETURNED FOR INVESTIGATION. NO ONE WAS HARMED BY THIS SMOKING ANALYZER AND NOPROPERTY WAS DAMAGED. THE CUSTOMER IMMEDIATELY UNPLUGGED THE INSTRUMENT WHEN THE SMOKE WAS SEEN. THE CUSTOMER IS OPERATIONAL WITH A NEW INSTRUMENT. THE CAUSE OF THIS EVENT IS UNKNOWN.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ WOULD NOT TURN ON AND A BURNT SMELL WAS OBSERVED. THE CUSTOMER ATTEMPTED PLUGGING THE UNIT INTO A DIFFERENT OUTLET, AND NOTED VISIBLE SMOKE.

Additional Manufacturer Narrative

SIEMENS HAS COMPLETED THE INVESTIGATION. THE D16 ON THE MAIN BOARD WAS SOURCE OF THE BURNING SMELL BUT IT IS NOT A FIRE RISK. D16 FAILS WHEN INCORRECT POWER IS CONNECTED TO THE DEVICE, EITHER THROUGH PLUGGING IN THE WRONG POWER SUPPLY (DEVICE USES A COMMON BARREL CONNECTOR) OR USING 3.5V RECHARGEABLE BATTERIES (DEVICE SPECIFIES USING COMMON 1.5V AA BATTERIES). ADDITIONALLY THIS CAN BE CAUSED NATURALLY IN THE EVENT OF A POWER SURGE. ALSO WORTH NOTING THE CUSTOMER IS UNSURE IF THE ORIGINAL POWER SUPPLY WAS IN USE AT THE TIME OF THIS EVENT. THERE IS NO DEFINITIVE CAUSE FOR THIS EVENT.

Remedial action

  • Replace