LNCS NEONATAL PROBE

Additional Manufacturer Narrative

IT WAS REPORTED; A REPROCESSED PULSE OX SENSOR WAS PLACED ON A NEWBORNS FOOT AND WHEN REMOVED A "SMALL BURN MARK WAS PRESENT ON THE INFANT'S FOOT DIRECTLY UNDER THE AREA THAT THE SENSOR LIGHT TOUCHED." THE REPORTER STATES ON (B)(6) 2020, A REPROCESSED MASIMO PULSE OXIMETER WAS PLACED ON THE TOP OF THE RIGHT FOOT OF A (B)(6) OLD NEWBORN IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THE REPORTER STATES, "FACILITY PROTOCOL IS TO MOVE THE SENSOR EVERY 8 HOURS AND PROTOCOL WAS FOLLOWED. WHEN THE NURSE REMOVED THE SENSOR, THEY NOTICED THERE WAS A SMALL BURN MARK ON THE INFANT'S FOOT DIRECTLY UNDER THE AREA THAT THE SENSOR LIGHT TOUCHED. THE PULSE OXIMETER WAS REMOVED AND THE AREA WAS CLEANED WITH NORMAL SALINE." REPORTER DESCRIBED THE AREA AS "INITIALLY RED THEN EXCORIATED THEN SCABBED OVER." THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION OR FOLLOW-UP. REPORTER STATES THE NEWBORN HAS "NO LASTING EFFECTS." THE SAMPLE HAS BEEN SHIPPED BACK FOR EVALUATION. THE INVESTIGATION/ROOT CAUSE HAS NOT YET BEEN DETERMINED. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED; A REPROCESSED MASIMO PULSE OXIMETER WAS PLACED ON A NEWBORNS FOOT AND WHEN REMOVED A "SMALL BURN MARK WAS PRESENT ON THE INFANT'S FOOT DIRECTLY UNDER THE AREA THAT THE SENSOR LIGHT TOUCHED."