CLINITEK STATUS+
Received Jun 3, 2019 · Event occurred May 14, 2019
Report 3002637618-2019-00065 · MDR key 8663174
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INSTRUMENT AND BATTERIES HAVE BEEN REQUESTED FOR INVESTIGATION. A NEW INSTRUMENT HAS BEEN SENT TO THE CUSTOMER. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ DID NOT POWER ON. SIEMENS SERVICE INSTRUCTED THE CUSTOMER TO UNPLUG THE UNIT AND INSTALL NEW BATTERIES. ONCE THE BATTERIES WERE INSTALLED, THE CUSTOMER ATTEMPTED TO TURN THE UNIT ON AND THEN SMELLED SMOKE. WHILE REMOVING THE BATTERIES THE CUSTOMER NOTICED SMOKE COMING FROM THE BATTERIES. SERVICE WAS NOT ABLE TO DETERMINE IF THE BATTERIES WERE INSTALLED PROPERLY AND HAD THE CUSTOMER REMOVE THE BATTERIES. A NEW CLINITEK STATUS+ WILL BE PROVIDED TO THE CUSTOMER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS TECH OPS HAS COMPLETED THE INVESTIGATION. THE FAILED BATTERY CAUSING THE BATTERY HOLDER TO MELT WAS THE SOURCE OF THE BURNING SMELL, BUT IS NOT A FIRE RISK. THIS FAILURE COULD HAVE OCCURRED DUE TO THE USE OF INCORRECT, EXPIRED OR RECHARGEABLE BATTERIES. IT IS SPECIFIED THAT THE STATUS SHALL BE USED WITH COMMON 1.5V AA BATTERIES. BATTERIES OUTSIDE OF THE SPECIFIED TYPE CAN BE SUSCEPTIBLE TO THERMAL RUNAWAY, CAUSING THE BATTERY TO GENERATE EXCESS HEAT EVENTUALLY RESULTING IN THE MELTING OF THE SURROUNDING PLASTIC. THE CUSTOMER STATED THAT THEY ARE FULLY FUNCTIONAL, AND THE UNIT IS BACK IN SERVICE.
Remedial action
- Replace