CLINITEK STATUS+
Received Aug 30, 2019 · Event occurred Jul 24, 2019
Report 3002637618-2019-00099 · MDR key 8951593
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
INVESTIGATION COMPLETED:THE CLINITEK STATUS WAS RECEIVED IN GOOD CONDITION WITH NO PHYSICAL DAMAGE TO THE EXTERIOR OF THE INSTRUMENT. THE DEVICE WAS RETURNED WITH THE APPROPRIATE POWER SUPPLY BUT WITHOUT BATTERIES. THE INSTRUMENT HAS D16 DAMAGE ON THE MAIN BOARD. THE 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 STATED THEY ARE OPERATIONAL WITH THE NEW INSTRUMENT.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED THE CUSTOMER RETURN THE INSTRUMENT AND BATTERIES FOR INVESTIGATION. THE CAUSE OF THE EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ WOULD NOT POWER ON. THEY TRIED A DIFFERENT POWER CORD AND OUTLET AND STILL NO POWER. WHEN THEY INSERTED BATTERIES, THE INSTRUMENT STARTED TO SMOKE FROM THE CASING OF THE INSTRUMENT, BEHIND THE DISPLAY. THE CUSTOMER STATED THERE WERE NO FLAMES OR INJURIES.
Remedial action
- Replace