BUBBLE DETECTOR SENSOR

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE SENSOR STOPPED SENSING AND WAS FOUND HARD TO ARM. THE BUBBLE SENSOR HAS BEEN REPLACED. 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 RECEIVED REPORT THAT A BUBBLE DETECTOR SENSOR STOPPED SENSING DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

LIVANOVA RECEIVED A REPORT THAT A BUBBLE DETECTOR SENSOR STOPPED SENSING DURING PROCEDURE. THERE WAS NO PATIENT INJURY. A LIVANOVA FIELD SERVICE TECHNICIAN COULD REPRODUCED THE ISSUE. BUBBLE SENSOR CUSHIONS DID NOT PRESENT ANY DEVIATION. A NEW BUBBLE SENSOR WAS INSTALLED AND NO DEVIATION WAS FOUND WHEN USING THE NEW BUBBLE SENSOR. THE ENTIRE S5 WAS RETURNED TO THE CUSTOMER THE ANALYSIS OF THE LIVANOVA COMPLAINTS DATABASE DID NOT REVEAL ANY OTHER SIMILAR EVENT FROM THIS CENTER. NO FURTHER SIMILAR EVENT FROM THE INSTALLATION DATE OCCURRED. THE MOST PROBABLE ROOT CAUSE OF THE ISSUE WAS A DEFECTIVE BUBBLE SENSOR. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

Description of Event or Problem

SEE INITIAL REPORT.