inforMED
MalfunctionJIL

CLINITEK STATUS+

Received Sep 8, 2020 · Event occurred Aug 14, 2020

Report 3002637618-2020-00046 · MDR key 10504191

Device

Generic name

Clinitek Status+

Model number

10379675

Catalog number

10379675

Product problems

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

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

SIEMENS HAS REQUESTED THE CUSTOMER'S INSTRUMENT AND BATTERIES TO BE RETURNED FOR INVESTIGATION. A NEW INSTRUMENT HAS BEEN SENT TO THE CUSTOMER.

Description of Event or Problem

THE CUSTOMER'S INSTRUMENT WOULD NOT POWER ON SO THEY INSERTED BATTERIES. WHEN THEY TURNED THE INSTRUMENT ON IT STARTED SMOKING. NO FLAMES WERE SEEN AND THERE WAS NO INJURY DUE TO THIS EVENT.

Additional Manufacturer Narrative

SIEMENS EVALUATED THE CLINITEK STATUS RETURNED BY THE CUSTOMER. THE INSTRUMENT WAS RETURNED IN FAIR CONDITION. THE INSTRUMENT WAS RETURNED WITH THE ORIGINAL POWER SUPPLY AND BATTERIES. 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