inforMED
MalfunctionJIL

CLINITEK STATUS+

Received Nov 20, 2020 · Event occurred Oct 26, 2020

Report 3002637618-2020-00066 · MDR key 10879482

Device

Generic name

Clinitek Status+

Model number

10379675

Catalog number

10379675

Product problems

  • Electrical /Electronic Property Problem
  • Electrical /Electronic Property Problem

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

SIEMENS HAS REQUESTED THE INSTRUMENT AND POWER SUPPLY BE RETURNED FOR INVESTIGATION AND THEY HAVE BEEN RECEIVED. THE INVESTIGATION TASK HAS BEEN OPENED. THE CAUSE OF THIS EVENT IS UNKNOWN.

Description of Event or Problem

THE CUSTOMER REPORTED SMOKE COMING FROM THE AREA BEHIND WHERE THE PAPER WOULD GO ON THE CLINITEK STATUS+ WHEN THEY FIRST TURNED IT ON. THEY WERE USING THE POWER SUPPLY PROVIDED WITH THE INSTRUMENT AND NO BATTERIES. THE CUSTOMER IMMEDIATELY CEASED USING THE INSTRUMENT, AND UNPLUGGED IT. NO FLAMES WERE SEEN. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

Additional Manufacturer Narrative

SIEMENS EVALUATED THE CLINITEK STATUS+ RETURNED BY THE CUSTOMER. THE INSTRUMENT WAS RETURNED WITH THE ORIGINAL POWER SUPPLY. THE INSTRUMENT HAS A D16 DAMAGE ON THE MAIN BOARD. 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). IN ADDITION THIS CAN BE CAUSED BY A NATURAL EVENT CAUSING A POWER SURGE.

Remedial action

  • Replace