BUBBLE DETECTOR SENSOR

Description of Event or Problem

LIVANOVA RECEIVED REPORT THAT A BUBBLE SENSOR DID NOT WORK DURING SETUP. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER TO CLARIFY THE MALFUNCTION AND NO RESPONSE HAS BEEN RECEIVED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

SEE INITIAL REPORT.

Additional Manufacturer Narrative

LIVANOVA ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER TO CLARIFY THE MALFUNCTION AND NO RESPONSE HAS BEEN RECEIVED. HOWEVER, LIVANOVA TECHNICIAN SUGGESTED TO CUSTOMER THE REPLACEMENT FOR INVOLVED SENSOR. COMPLAINTS DATABASE ANALYSIS ON S5 CONSOLE WHICH THE COMPLAINED BUBBLE SENSOR WAS USED ON (SERIAL NUMBER (B)(6)) REVEALED NO EVENT OF BUBBLE SENSOR MALFUNCTION SINCE MACHINE INSTALLATION IN 2012. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.