DOLPHIN 2000/3000 OXIMETRY SENSORS - Y MULTISITE REUSABLE OXIMETRY SENSOR

Description of Event or Problem

IT WAS REPORTED, "SPO2 PROBE CAUSED A STAGE 2 ULCER ON A (B)(6) FEMALE PATIENT'S UPPER EAR IN THE CRITICAL CARE CENTER. THIS REPORT WAS MADE DURING (B)(4). THE PATIENT WAS NOT DIABETIC AND THE NURSES BELIEVE THE EAR PROBE WAS MOVED FROM THE LOBE TO UPPER EAR WITHIN AN 8 HOUR TIME FRAME. THERE WAS NO PHYSICAL DAMAGE FOUND ON THE T SITE LEAD, EMITTER, DETECTOR, OR PLASTIC EAR CLIP." THE PATIENT WAS MOVED FROM CRITICAL CARE CENTER TO ANOTHER UNIT; BUT WAS DOING WELL. THE PATIENT WAS TREATED AND MONITORED BY THE END-USER FACILITY WOUND CARE/OSTOMY NURSE. THE DEVICE WAS RETURNED TO CONMED CORPORATION BY THE END-USER FACILITY ON (B)(6) 2013. THE DEVICE WAS TRANSFERRED TO THE MANUFACTURER FOR EVALUATION ON (B)(6) 2013. (B)(4).