S-CATH M ESOPHAGEAL TEMPERATURE PROBE

Additional Manufacturer Narrative

EXAMINATION SHOWS THE PEBAX LAYER WAS THIN AT THE ELECTRODE BAND EDGES. DURING PROBE INSERTION AND REMOVAL, THE FRICTION CAUSED THE PEBAX TO PEEL AWAY, THEREBY EXPOSING THE ELECTRODE BAND EDGE.

Description of Event or Problem

THE CUSTOMER USED A NEW CS-46EP AND REPORTS THAT WHEN THE PROBE WAS REMOVED, THERE WAS RESISTANCE IN THE NOSE, AND IT STARTED TO BLEED HEAVILY; THE BLEEDING COULD ONLY BE STOPPED THE NEXT DAY. HE ALSO REPORTED THAT THE SURFACE OF THE PROBE IN THE AREA OF THE ELECTRODES WAS BADLY DAMAGED.