TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

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 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, DURING A SURGICAL PROCESS, THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) DID NOT PERFORM READINGS. AS PER CUSTOMER'S OPINION, THERE WAS A FOREIGN OBJECT BLOCKING THE TUBING. TO SOLVE THE ISSUE, THE DEVICE WAS REPLACED. THERE WAS NO ALLEGATION OF PATIENT INJURY.