inforMED
MalfunctionJIL

CLINITEK STATUS+

Received Apr 25, 2024 · Event occurred Apr 18, 2024

Report 3002637618-2024-00046 · MDR key 19180547

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

UPON INVESTIGATION, EVIDENCE OF VOLTAGE OVERLOAD ON THE MAIN BOARD WAS IDENTIFIED. SPECIFICALLY, THE D16 DIODE WAS DAMAGED. WHEN A D16 COMPONENT FAILS, THE CONTENTS ON THE INSIDE MAY APPEAR AS SMOKE. FURTHERMORE, D16 FAILS WHEN AN INCORRECT POWER SOURCE IS CONNECTED TO THE DEVICE, THROUGH PLUGGING IN THE WRONG POWER SUPPLY OR THIS CAN BE CAUSED BY ANY NATURAL EVENT CAUSING A POWER SURGE. ALTHOUGH DAMAGE TO THE D16 DIODE WAS IDENTIFIED, THE SOURCE OF THE HIGH VOLTAGE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE D16 ON THE MAIN BOARD WAS THE LIKELY SOURCE OF THE LIGHT SMOKE PRODUCED, BUT IT IS NOT A FIRE RISK DUE TO PLASTICS BEING 94V0. THE RECOMMENDATION FROM SIEMENS IS TO ENSURE THAT APPROPRIATE POWER SOURCE IS USED, OR TO USE A POWER CONDITIONER TO PREVENT UNINTERRUPTED POWER OR SURGES.

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.

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 SHOWED DUE DILIGENCE IN ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE RETURN OF THE PRODUCT. HOWEVER, TO DATE, THERE HAVE NOT BEEN ANY ADDITIONAL UPDATES ON THE RETURN. WITHOUT THE REQUESTED PRODUCT, THE INVESTIGATION COULD NOT PROCEED. THE D16 COMPONENT CAN FAIL 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). THIS CAN ALSO BE CAUSED BY ANY NATURAL EVENT WHICH CAUSES A POWER SURGE. THIS CAN CAUSE SOME SMOKE TO APPEAR, BUT IT IS NOT A FIRE RISK. HOWEVER, WITHOUT THE RETURN OF THIS INSTRUMENT THIS CANNOT BE CONFIRMED. THE CAUSE OF THIS EVENT IS UNKNOWN.