TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

ADDED INFORMATION TO SECTION D9. UPDATED SECTION H6 (COMPONENT CODE), H6 (TYPE OF INVESTIGATION), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). THE DEVICE WAS RECEIVED FOR EVALUATION. THE REPORT OF INACCURATE PRESSURE VALUE WAS UNABLE TO BE CONFIRMED. DPT ZEROED AND SENSED PRESSURE ACCURATELY ON PRESSURE MONITOR. NO ERROR MESSAGE WAS NOTICED ON THE MONITOR. PRESSURE DID NOT SHOW ANY DRIFT DURING OUTPUT DRIFT TESTING AND MET SPECIFICATION. ELECTRICAL TESTING SHOWED THAT BOTH INPUT IMPEDANCE AND OUTPUT IMPEDANCE WERE WITHIN SPECIFICATIONS. ZERO-OFFSET (0 MMHG) ALSO MET SPECIFICATION. NO VISIBLE DAMAGE WAS FOUND FROM THE KIT. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT INVOLVED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. DURING THE MANUFACTURING PROCESS THERE ARE CONTROLS RELATED TO THE REPORTED MALFUNCTION.

Additional Manufacturer Narrative

COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

Description of Event or Problem

AS REPORTED, USE IN A PATIENT WITH AN AORTIC VALVE CONDITION, THIS PRESSURE MONITORING SET SHOWED A MEAN ARTERIAL PRESSURE (MAP) OF 33 MMHG, WHEN THE EXPECTED MAP BASED ON THE PATIENT'S CONDITION WAS 60-65 MMHG. NO ERROR MESSAGE WAS DISPLAYED. THE ISSUE WAS SOLVED REPLACING THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.