S3 BUBBLE DETECTOR

Additional Manufacturer Narrative

LIVANOVA (B)(4) MANUFACTURES THE S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THE REPLACED S3 BUBBLE DETECTOR WAS RETURNED TO LIVANOVA USA FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE ISSUE AND REVEALED EVIDENCE OF PHYSICAL DAMAGE (DINGS AND SCRATCHES) IN VARIOUS LOCATIONS ON THE SENSOR BODY, AND THE BLADDERS WERE SLIGHTLY DEFLATED. THE SENSOR WAS SCRAPPED UPON COMPLETION OF THE INVESTIGATION. THE ROOT CAUSE OF THE DEFLATED CUSHIONS COULD NOT BE DETERMINED. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS TYPE OF ISSUE.

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA (B)(4) MANUFACTURES THE S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE CONFIRMED THE REPORTED ISSUE AND REPLACED THE S3 BUBBLE DETECTOR. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

Description of Event or Problem

LIVANOVA (B)(4) RECEIVED A REPORT THAT THE S3 BUBBLE DETECTOR HAD DEFLATED BLADDERS AND FAILED TWICE DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.