TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, AFTER CONNECTING THIS PRESSURE MONITORING SET TO THE PATIENT'S RADIAL ARTERY, THE PRESSURE VALUES OBTAINED (75/47 MMHG) DIFFERED SIGNIFICANTLY FROM THE PREOPERATIVE NON-INVASIVE CUFF MEASUREMENT (135/85 MMHG). NO ABNORMAL ALARMS OR ALERTS WERE OBSERVED. THE PRESSURE MONITORING SET WAS REPLACED WITH A NEW UNIT, AFTER WHICH NORMAL PRESSURE READINGS (143/88 MMHG) WERE OBTAINED. THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON THE INACCURATE READINGS. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

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.