EV1000

Additional Manufacturer Narrative

ADDITIONAL FDA PRODUCT CODES INCLUDE: DXN- SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. DQK- COMPUTER, DIAGNOSTIC, PROGRAMMABLE. QAQ- ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. DXG- COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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 A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT DURING SET UP OF THE PRESSURE CONTROLLER KIT, IT WAS GIVING INCONSISTENT READINGS. THE REP EXCHANGED THE DEVICE FOR A NEW ONE AND THE ISSUE RESOLVED. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

ONE HEMOSPHERE PRESSURE CONTROLLER WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS NOT CONFIRMED. THE DEVICE WAS CONNECTED TO A KNOWN WORKING HEMOSPHERE SYSTEM AND MONITORED A CUFF SIMULATOR FOR OVER AN HOUR. THE READINGS WERE ACCURATE AND CONSISTENT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SINCE THE COMPLAINT AFFECTED UNIT WAS RETURNED FOR EVALUATION AND NO DEFECT WAS FOUND, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE STATES PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: DO NOT OVERTIGHTEN THE PRESSURE CONTROLLER BAND. DO NOT APPLY PRESSURE CONTROLLER BAND ON INJURED SKIN AS THIS CAN CAUSE FURTHER INJURY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.