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 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, PRIOR TO CONNECTION TO THE PATIENT, THE PRESSURE TUBING OF THIS TRIPLE PRESSURE MONITORING SET WITH VAMP ADULT SYSTEM BECAME DETACHED FROM THE YELLOW STAND-ALONE STOPCOCK. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.