CLINITEK STATUS+

Additional Manufacturer Narrative

SIEMENS EVALUATED THE CLINITEK STATUS+ RETURNED BY THE CUSTOMER. THE DEVICE WAS RETURNED WITH THE APPROPRIATE POWER CORD BUT WITHOUT ANY BATTERIES. THE D16 ON THE MAIN BOARD WAS THE SOURCE OF THE BURNING SMELL AND SMOKE 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 ANY NATURAL EVENT CAUSING A POWER SURGE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE OPERATOR OF THE CLINITEK STATUS+ COULD NOT POWER ON THE UNIT. WHEN THE BIOMEDICAL ENGINEER WENT ON SITE TO SERVICE THE UNIT, HE PLUGGED IT IN AND THE UNIT BEGAN TO SMOKE. HE IMMEDIATELY DISCONNECTED THE UNIT. NO VISIBLE FLAMES WERE SEEN. THE CLINITEK STATUS+ HAS BEEN REPLACED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.