TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

CORRECTED SECTION G1 (CONTACT OFFICE TELEPHONE NUMBER). UPDATED SECTION H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). THE DEVICE WAS RECEIVED FOR EVALUATION. THE REPORT OF PRESSURE TUBING DETACHED WAS UNABLE TO BE CONFIRMED, SINCE NO DEFECT WAS FOUND ON THE RETURNED DEVICE. AS RECEIVED, ALL CONNECTIONS WERE TIGHT AND SECURE. ADDITIONALLY, NO LEAKAGE WAS DETECTED FROM THE KIT DURING LEAK TEST AND NO VISIBLE DAMAGE NOR DEFECT WAS OBSERVED FROM THE KIT. FINALLY, BOTH DPTS (DISPOSABLE PRESSURE TRANSDUCER) ZEROED AND SENSED PRESSURE ACCURATELY ON PRESSURE MONITOR. NO FURTHER INVESTIGATION COULD BE PERFORMED AS NO DEFECT WAS FOUND ON THE RETURNED DEVICE. INTERNAL CONTROLS ARE IN PLACE DURING THE MANUFACTURING PROCESS TO AVOID POTENTIAL CAUSES ASSOCIATED WITH THE REPORTED MALFUNCTION, SUCH AS SAMPLING AND VISUAL INSPECTION TO VERIFY THE INTEGRITY OF THE DEVICE.

Additional Manufacturer Narrative

PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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, BEFORE USE IN PATIENT, THE PRESSURE TUBING OF THIS DISPOSABLE PRESSURE TRANSDUCER WAS DETACHED AT THE TOP OF THE SENSOR. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.