PRESSURE MONITORING KIT

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. 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 A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

AS REPORTED, DURING USE, A PRESSURE MONITORING KIT DISPLAYED NEGATIVE PULMONARY ARTERY PRESSURES. EXACT MEASUREMENTS ARE UNKNOWN. DEVICE WAS ABLE TO ZERO BEFORE USE. THOUGH THE CABLE WAS REPLACED, THE PROBLEM WAS NOT SOLVED. THE PRESSURE MONITORING KIT WAS NOT REPLACED, AND THE CUSTOMER CONTINUED TO MONITOR PATIENT CONDITION USING THE OTHER PARAMETERS EXCEPT FOR THE PULMONARY ARTERY PRESSURE. A NIHON KOHDEN PATIENT MONITOR WAS USED DURING THE CASE. IT IS UNKNOWN IF AN ERROR MESSAGE WAS DISPLAYED. NO OCCLUSION, LEAKAGE NOR KINK WAS FOUND. PATIENT WAS NOT TREATED FOR THE INACCURATE VALUE. THERE WAS NO ALLEGATION OF PATIENT INJURY.