TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, DURING USE IN PATIENT OF THIS PRESSURE MONITORING SET, LOW PRESSURE READINGS WERE PROVIDED. RELEVELING, REZEROING AND REPLACING THE PRESSURE CABLE DID NOT FIX THE PROBLEM. NO ERROR MESSAGE NOR ABNORMAL WAVEFORM WERE OBSERVED. FINALLY, ISSUE WAS SOLVED REPLACING THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT WAS NOT TREATED BASED ON THE VALUES CONSIDERED INACCURATE. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

Additional Manufacturer Narrative

THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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.