BUBBLE DETECTOR

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA (B)(4) MANUFACTURES THE BUBBLE SENSOR. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA PERFORMED ATTEMPT TO RETRIEVE ADDITIONAL INFORMATION TO CLARIFY THE MALFUNCTION OF THE THREE (3) BUBBLE SENSORS. NO REPLY HAS BEEN RECEIVED YET AND THE SERIAL NUMBERS ARE UNKNOWN. 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 THREE (3) BUBBLE SENSORS ARE DEFECTIVE. THE ISSUE WAS IDENTIFIED DURING PRIMING. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NUMBERS ARE UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER LIVANOVA LEARNED THAT THE CUSTOMER SCRAPPED THE BUBBLE SENSOR SO NO SERIAL NUMBER CAN BE PROVIDED.IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.