TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

UPDATED SECTIONS B5 (EVENT DESCRIPTION), D9 (DEVICE AVAILABILITY), G1 (CONTACT OFFICE EMAIL ADDRESS AND TELEPHONE NUMBER), H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS) ADDED INFORMATION IN SECTIONS E2 (HEALTH PROFESSIONAL) AND E4 (INITIAL REPORTED ALSO SENT THE REPORT TO FDA) THE DEVICE WAS RECEIVED FOR EVALUATION. THE REPORT OF INACCURATE VALUES WAS UNABLE TO CONFIRMED. THE DISPOSABLE PRESSURE TRANSDUCER (DPT) SENSOR DID NOT ZERO NOR SENSED PRESSURE ON PRESSURE MONITOR. ELECTRICAL TESTING SHOWED BOTH INPUT AND OUTPUT IMPEDANCES WERE UNSTABLE IF MEASURED FROM THE DPT SENSOR CABLE CONNECTOR. HOWEVER, ELECTRICAL TESTING SHOWED THAT INPUT AND OUTPUT IMPEDANCES MEASURED FROM THE SENSOR CHIP WERE WITHIN SPECIFICATIONS. CORROSION WAS OBSERVED ON CONTACT PLATES OF THE DPT SENSOR CABLE CONNECTOR. CORROSION WAS LIKELY CAUSED BY LIQUID. ALL SOLDER JOINTS OF BOTH INPUT AND OUTPUT CIRCUITS WERE CORRODED WITH WHAT APPEARED TO BE SALT-LIKE MATERIAL. WHITE SALT LIKE MATERIAL WAS NOT EVIDENT AT THE TEST PORT. NO LEAKAGE WAS DETECTED FROM THE KIT DURING THE LEAK TEST. THE FLUSH DEVICE OF THE DPT HOUSING WAS INTACT AND NO OTHER VISIBLE DAMAGE OR DEFECT WAS OBSERVED FROM THE KIT. BASED ON FURTHER ENGINEERING INVESTIGATION, A POTENTIAL ROOT CAUSE FOR THIS CONDITION COULD NOT BE IDENTIFIED. IT WAS VERIFIED THERE ARE MANUFACTURING CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THIS MALFUNCTION, SUCH AS ELECTRICAL TESTING AND VISUAL INSPECTIONS. THE MANUFACTURING PERSONNEL WAS NOTIFIED FOR AWARENESS.

Description of Event or Problem

AS REPORTED, DURING USE IN A PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER (DPT), THE (MAP) PRESSURE VALUE DISPLAYED WAS 55 MMHG, WHEN THE EXPECTED VALUES ACCORDING TO THE PATIENT'S CONDITIONS WAS 80MMHG. THERE WAS NO ERROR MESSAGE DISPLAYED. THE VALUES RETURNED TO NORMAL AFTER REPLACING THE SENSOR WITH A NEW ONE. THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON THE WRONG VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

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. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED, THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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 A PATIENT WITH THIS DISPOSABLE PRESSURE TRANSDUCER (DPT), THE (MAP) PRESSURE VALUE DISPLAYED WAS 55 MMHG, WHEN THE EXPECTED VALUES ACCORDING TO THE PATIENT'S CONDITIONS WAS 80MMHG. THERE WAS AN UNKNOWN ERROR MESSAGE DISPLAYED. THE VALUES RETURNED TO NORMAL AFTER REPLACING THE SENSOR WITH A NEW ONE. THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON THE WRONG VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.