FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER

Description of Event or Problem

AS REPORTED, AS PER CUSTOMER FEEDBACK, DUE TO CHALLENGES WITH SENSOR PLACEMENT AND CLINICAL INTERPRETATION, THE FORESIGHT SENSOR HAD VARIABILITY IN ABSOLUTE REGIONAL HEMOGLOBIN OXYGEN SATURATION OF BLOOD (STO2) READINGS. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

OCCURRENCE DATE UNKNOWN. MODEL NUMBER UNKNOWN. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THE EVENT WAS REPORTED THROUGH AN ANONYMOUS SURVEY; THEREFORE, THE IDENTITY OF THE HOSPITAL REMAINS CONFIDENTIAL, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. NO PRODUCT WAS RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.