S5 BUBBLE SENSOR MODULE

Additional Manufacturer Narrative

(B)(4) MANUFACTURES THE S5 BUBBLE SENSOR MODULE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF (B)(4). A (B)(4) FIELD SERVICE REPRESENTATIVE SHIPPED A NEW BUBBLE SENSOR TO THE CUSTOMER. THE CUSTOMER PLANS TO INSTALL THE NEW BUBBLE SENSOR ON THEIR OWN. 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

(B)(4) RECEIVED A REPORT THAT THE S5 BUBBLE SENSOR MODULE ALARMED DURING A PROCEDURE WHEN NO BUBBLE WAS PRESENT, AND THAT THE 1/4" BUBBLE SENSOR WAS NOT RECOGNIZED. THERE WAS NO REPORT OF PATIENT INJURY.

Additional Manufacturer Narrative

THIS IS A FOLLOW UP TO THE INITIAL MDR SUBMITTED. THE TECHNICIAN TESTED THE BUBBLE SENSOR ON THE S5 TEST BED AND ENCOUNTERED CONSTANT BUBBLE ALARMS WHETHER BUBBLES WERE PRESENT OR NOT, THE REPORTED FAILURE WAS CONFIRMED. THE DESCRIBED ERROR COULD BE REPRODUCED; CAUSE OF THE FAULT; 1/4´´ BUBBLE SENSOR IS DEFECT. THE ROOT-CAUSE WAS DETERMINED TO BE SENSOR OUT OF CALIBRATION (CERAMIC PLATE IS BROKEN). THE BUBBLE SENSOR WILL BE SCRAPPED. CORRECTION TO MFR SITE TO REFLECT CHANGES TO MANUFACTURERS NAME.