S3 BUBB DET SENSOR, LOW LEVEL II

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S3 BUBBLE DET SENSOR, LOW LEVEL II. THE INCIDENT OCCURRED IN (B)(6). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA (B)(4) LEARNED THAT THE USER CHECKED THE SENSOR PAD AS FIRST, THEN HE USED A SENSOR FROM ANOTHER MACHINE TO RESOLVE THE ISSUE. A NEW LEVEL SENSOR WAS SHIPPED TO THE HOSPITAL. THROUGH FURTHER FOLLOW-UP COMMUNICATION LIVANOVA (B)(4) LEARNED THAT THE SENSOR WAS PROPERLY CONNECTED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

LIVANOVA (B)(4) RECEIVED A REPORT THAT A S3 BUBBLE DET SENSOR, LOW LEVEL II DID NOT ALARM WHEN RESERVOIR WAS EMPTY DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.