CLINITEK STATUS+ USA
Received Jun 21, 2021 · Event occurred Jun 7, 2021
Report 3002637618-2021-00040 · MDR key 12033063
Device
Generic name
Clinitek Status+
Manufacturer
Siemens Healthcare DiagnosticsModel number
10379675Catalog number
10379675
Product problems
- Smoking
- Smoking
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION: THE INSTRUMENT WAS RETURNED AS AN INSTRUMENT ONLY. NO BATTERIES OR POWER SUPPLY WERE RETURNED WITH THE 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. WHEN OPENING THE CLINITEK STATUS+, FAINT SMOKE STAINS WERE NOTED ON THE PLASTICS DIRECTLY ABOVE COMPONENT D16. IN ADDITION, FAILURE OF D16 WAS CONFIRMED USING A MULTIMETER.
Additional Manufacturer Narrative
THE CUSTOMER HAS RECEIVED A NEW UNIT AND HAS RETURNED THE CLINITEK STATUS+ TO SIEMENS FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ BEGAN TO EMIT A BURNING SMELL AFTER ATTEMPTING TO POWER IT ON. UPON INSERTING NEW BATTERIES, THEIR SYSTEM WOULDN'T START AND BEGAN TO EMIT VISIBLE SMOKE. THERE WERE NO VISIBLE FLAMES. THEIR WAS NO REPORT OF HARM TO THE OPERATOR OR ANYONE ELSE AND NO DAMAGE TO ANY PROPERTY.
Remedial action
- Replace