RD SET TC-I

Additional Manufacturer Narrative

ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE MASIMO CLINICAL SPECIALIST NOTED THAT THE CUSTOMER WAS CONCERNED ABOUT DIFFERENCES BETWEEN THE MASIMO AND NELLCOR RESULTS BUT THAT THERE WAS NO INFORMATION THAT SUGGESTS TREATMENT WAS GIVEN OR WITHHELD BASED ON THE SPO2 MEASUREMENTS, AND THE CUSTOMER DID NOT CLAIM THAT MASIMO TECHNOLOGY CAUSED OR CONTRIBUTED TO ADVERSE CONSEQUENCES FOR THE PATIENT.

Description of Event or Problem

AT 5:30 AM ON (B)(6) 2018 THE PATIENT WAS ADMITTED POST CARDIAC ARREST WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). PATIENT WAS PLACED ON A VENTILATOR, IN A PRONE POSITION, FIO2 0.60, PEEP +10. THE CUSTOMER REPORTED THAT THE MASIMO SPO2 READINGS WERE HIGHER THAN THE BLOOD DRAW. THE CUSTOMER CHANGED TO A NELLCOR SENSOR AND THE SPO2 READINGS WERE LOWER. THE PATIENT EXPIRED THE MORNING OF (B)(6) 2018.