TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

AS PER FURTHER CLARIFICATION, UPDATED SECTION B5. ADDED INFORMATION TO SECTION B3, H6 (TYPE OF INVESTIGATION) UPDATED SECTION H6 (COMPONENT CODE), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. FINALLY, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION DESPITE DUE DILIGENT ATTEMPTS. WITHOUT RETURN OF THE PRODUCT, A COMPLETE INVESTIGATION OF THE REPORTED EVENT IS UNABLE TO BE PERFORMED. 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. REVIEWS REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. AS SUCH, BASED ON AVAILABLE INFORMATION, A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. THERE ARE MANUFACTURING CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION.

Description of Event or Problem

AS REPORTED, BEFORE USE IN PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER (DPT), SOME SUBSTANCE WAS OBSERVED IN THE TUBE. ADDITIONALLY, THE DPT COULD NOT BE ZEROED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

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.

Description of Event or Problem

AS REPORTED, THIS DISPOSABLE PRESSURE TRANSDUCER HAD SOME SUBSTANCE IN THE TUBE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.