CLINITEK STATUS+
Received Nov 28, 2018 · Event occurred Nov 6, 2018
Report 3002637618-2018-00131 · MDR key 8112533
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION INTO THE SMOKE COMING FROM THE CLINITEK STATUS+. THE CONCLUSION IS THAT 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 (STATUS USES A COMMON BARREL CONNECTOR) OR USING 3.5V RECHARGEABLE BATTERIES (DEVICE SPECIFIES USING COMMON 1.5V AA BATTERIES). THE CUSTOMER IS OPERATIONAL WITH A NEW INSTRUMENT.
Additional Manufacturer Narrative
SIEMENS HAS REPLACED THE INSTRUMENT AND HAS REQUESTED THE ORIGINAL INSTRUMENT TO BE RETURNED FOR INVESTIGATION. THE CAUSE OF THE EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE CLINITEK STATUS+ STARTED SMOKING FROM THE PAPER SLOT WHEN PRINTING A RESULT. THERE WERE NO FLAMES. THE INSTRUMENT HAS BEEN UNPLUGGED AND HAS NOT BEEN USED. THERE WAS NO INJURY REPORTED DUE TO THIS EVENT.
Remedial action
- Replace