PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

ONE DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED PER PROCEDURE. THE TESTING COULD NOT DUPLICATE THE CUSTOMER REPORTED PROBLEM. NO EVENTS WERE OBSERVED WHERE PRESSURE WAS NOT APPLIED. HOWEVER, THERE WAS A DAMAGED PRESSURE GAUGE PROBLEM IDENTIFIED. THE ROOT CAUSE OF THE ISSUE WAS UNKNOWN AS THE ISSUE CANNOT BE REPRODUCED. THE CIRCUIT BOARD WAS RENEWED. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

Additional Manufacturer Narrative

B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE COULD NOT BE PRESSURED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.