SEDLINE SEDITATION MONITOR

Additional Manufacturer Narrative

OTHER, OTHER TEXT: MASIMO HAS REACHED OUT TO THE CUSTOMER TO REQUEST THE RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE DEVICE IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITT

Description of Event or Problem

THE CUSTOMER REPORTED "WE ARE SEEING 3-5 SEDLINE CABLE FAILURES A WEEK THAT IMPACT SURGERY IN REAL TIME. THE SEDLINE MODULE AND CABLE EXPERIENCE FAILURES THAT CAUSE THE MD TO BE UNABLE TO EVALUATE THE PATIENT'S DEPTH OF ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.