TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

UPDATED SECTION H6 (DEVICE CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). CUSTOMER REPORT OF "INACCURATE VALUES" WAS UNABLE TO BE CONFIRMED. THE DPT (DISPOSABLE PRESSURE TRANSDUCER) ZEROED AND SENSED PRESSURE ACCURATELY ON PRESSURE MONITOR. PRESSURE DID NOT SHOW ANY DRIFT DURING OUTPUT DRIFT TESTING AND MET SPECIFICATION. ELECTRICAL TESTING SHOWED THAT BOTH INPUT AND OUTPUT IMPEDANCES WERE WITHIN SPECIFICATIONS. ZERO-OFFSET ALSO MET SPECIFICATION. NO LEAKAGE OR OCCLUSION WAS DETECTED FROM THE SENSOR DURING PRESSURE TEST. NO VISIBLE DAMAGE WAS OBSERVED FROM THE SENSOR. 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. THERE ARE INTERNAL CONTROLS DURING THE MANUFACTURING PROCESS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION, SUCH AS FLOW, LEAK, VOLTAGE TEST AND ELECTRICAL TEST. ALL EVENTS WILL CONTINUE TO BE REVIEWED AND MONITORED.

Additional Manufacturer Narrative

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. 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.

Description of Event or Problem

AS REPORTED, DURING USE IN PATIENT THIS PRESSURE MONITORING SET DISPLAYED INACCURATE VALUES. THE DATA DISPLAYED DIFFERED GREATLY FROM THE EXPECTED VALUES ACCORDING TO THE PATIENT'S CONDITIONS. THERE WAS NO COMPARATIVE DATA OBTAINED FROM ANOTHER SOURCE. REPLACING THE SENSOR WITH A NEW ONE SOLVED THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RECEIVED FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.