CLINITEK STATUS+ USA

Additional Manufacturer Narrative

SIEMENS SHOWED DUE DILIGENCE IN ATTEMPTING TO OBTAIN A RETURN OF THE AFFECTED INSTRUMENT. THE CUSTOMER DID NOT USE THE SHIPPING LABEL THAT WAS PROVIDED AND THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION. WITHOUT THE RETURNED INSTRUMENT, THE INVESTIGATION CANNOT PROCEED AND THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED.

Additional Manufacturer Narrative

A REPLACEMENT CLINITEK STATUS+ HAS BEEN DELIVERED TO THE CUSTOMER. SIEMENS HAS REQUESTED THE OLD INSTRUMENT TO BE SENT BACK FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ SPARKED, AND SMOKE WAS EMITTED FROM THE FRONT OF THE DEVICE. THE ORIGINAL POWER CORD WAS IN USE AT THE TIME. THERE IS NO REPORT OF ANY INJURY TO ANY PATIENT OR OPERATOR DUE TO THIS EVENT.