PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

OTHER TEXT: D10, H6: EVENT METHODS, EVALUATION, AND CONCLUSION CODES: UPDATED. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. DURING VISUAL INSPECTION THE DEVICE WAS OBSERVED TO HAVE NO DAMAGE OR ANOMALIES. THE REPORTED ISSUE WAS CONFIRMED DURING FUNCTIONAL TESTING WHEN THE DEVICE INFLATOR INDICATOR REMAINED IN THE ZERO POSITION WHILE PRESSURE WAS APPLIED. THE INVESTIGATION DETERMINED THIS CONDITION WAS DUE TO DAMAGE CAUSED BY A DROP OR IMPACT, BUT COULD NOT ATTRIBUTE A ROOT CAUSE FOR THIS OCCURRENCE. THE LOT NUMBER PROVIDED WAS TRACED TO A PAIR OF FINISHED GOOD WORK ORDERS, WHICH WERE REVIEWED FOR DISCREPANCIES OR ANOMALIES. HOWEVER, NO INFORMATION RELATED TO THE REPORTED ISSUE WAS IDENTIFIED. WITH NO MANUFACTURING RELATED ISSUES IDENTIFIED, NO ACTIONS HAVE BEEN ASSIGNED AT THIS TIME.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: B3: DATE OF EVENT; D4: UDI NUMBER AND G5: 510K IS UNKNOWN. NO PRODUCT 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 POINTER ON THE MANOMETER DID NOT MOVE ON ANY OCCASION. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.