inforMED
MalfunctionJIL

CLINITEK STATUS+

Received Sep 24, 2019 · Event occurred Sep 6, 2019

Report 3002637618-2019-00102 · MDR key 9110126

Device

Generic name

Clinitek Status+

Catalog number

10379675

Product problems

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

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

THE CLINITEK STATUS+ WAS RETURNED IN GOOD CONDITION WITH NO DAMAGE TO THE EXTERIOR OF THE INSTRUMENT. THE INSTRUMENT WAS RETURNED WITHOUT A POWER SUPPLY OR BATTERIES. THE INSTRUMENT HAS D16 DAMAGE ON MAIN BOARD. D16 FAILURE CAUSED THE SYSTEM TO NOT OPERATE. THE D16 WAS THE 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). THE CUSTOMER IS OPERATIONAL WITH THE NEW INSTRUMENT.

Additional Manufacturer Narrative

SIEMENS HAS REQUESTED THE INSTRUMENT AND BATTERIES TO BE RETURNED FOR INVESTIGATION. THE INSTRUMENT HAS BEEN RECEIVED BUT THE BATTERIES WERE NOT INCLUDED. A REPLACEMENT CLINITEK STATUS+ HAS BEEN SENT TO THE CUSTOMER.

Description of Event or Problem

THE CUSTOMER REPORTED THEIR CLINITEK STATUS+ WOULD NOT TURN ON. THE OPERATOR REMOVED THE POWER CORD AND INSTALLED BATTERIES. THEN POWERED ON THE INSTRUMENT WITH THE POWER BUTTON AND IT TURNED ON. SOON AFTER, THE OPERATOR SAW AND SMELLED SMOKE COMING OUT FROM THE AREA UNDER THE PRINTER COVER. THERE WERE NO FLAMES AND NO INJURIES. THE CUSTOMER WAS INSTRUCTED TO LEAVE THE INSTRUMENT OFF.

Remedial action

  • Replace