CLINITEK STATUS+
Received May 12, 2022 · Event occurred Apr 29, 2022
Report 3002637618-2022-00031 · MDR key 14374152
Device
Generic name
Clinitek Status+
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
10379675Catalog number
10379675
Product problems
- Smoking
- Smoking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED THE RETURN OF THE INSTRUMENT. THE CUSTOMER HAS STATED THAT THE BATTERIES IN USE AT THE TIME OF THE EVENT HAVE BEEN DISCARDED. INVESTIGATION WILL PROCEED WHEN THE INSTRUMENT HAS BEEN RECEIVED THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR INSTRUMENT PRODUCED SMOKE WHEN ATTEMPTING TO POWER IT USING BATTERIES. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION OF THE RETURNED INSTRUMENT. THE D16 ON THE MAIN BOARD 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). IN ADDITION, THIS CAN BE CAUSED BY ANY NATURAL EVENT CAUSING A POWER SURGE. THE CUSTOMER STATED THAT THE EVENT OCCURED WHEN POWERING THE INSTRUMENT WITH ONLY BATTERIES. THE BATTERIES WERE DISCARDED BY THE CUSTOMER AND THEREFORE THE CAUSE OF THIS EVENT IS UNKNOWN.