TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

UPON THE RETURN OF THE PRODUCT AN INVESTIGATION WILL BE COMPLETED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND 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, THIS PRESSURE MONITORING SET DISPLAYED INACCURATE PRESSURE VALUES OF 0.2. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE PRESSURE VALUES PROVIDED, AND THE VALUES WERE NOT COMPARED WITH ANOTHER SOURCE. THERE IS NO ALLEGATION OF PATIENT INJURY.