EV1000

Additional Manufacturer Narrative

ONE PRESSURE CONTROLLER WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS UNABLE TO BE CONFIRMED. WHEN CONNECTED TO A KNOWN WORKING HEMOSPHERE SYSTEM THIS PRESSURE CONTROLLER POWERED UP WITH NO FAULTS. IT WAS CONNECTED TO A KNOWN WORKING HRS AND ZEROED IT WITH NO FAULTS. WHEN A CUFF SIMULATOR WAS SET TO 120 OVER 80 THE CUFF 1 PORT GAVE READINGS OR 123/75 AND CUFF 2 GAVE READINGS OF 124 OVER 75. THIS IS WITHIN THE SIMULATOR LIMITS. WITH VISUAL INSPECTION, UPPER AND LOWER HOUSINGS WERE BOTH CRACKED ON THE CUFF 2 SIDE. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT ANY NONCONFORMANCES. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS NO DEFECT WAS FOUND WITH THE DEVICE, THE ROOT CAUSE OF THE ALLEGED COMPLAINT IS UNABLE TO BE DETERMINED AT THIS TIME NOR IS THERE EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING CAUTIONS: INACCURATE MEASUREMENTS CAN BE CAUSED BY IMPORPERLY ZEROED OR LEVELED SENSORS OR TRANSDUCERS, OVER OR UNDER DAMPED PRESSURE LINES, EXCESSIVE VARIATIONS IN BLOOD PRESSURES, EXCESSIVE PATIENT MOVEMENT OR ELECTROCAUTERY OR ELECTORSUGICAL UNIT INTERFERENCE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PRESSURE CONTROLLER IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 70 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 30 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON. IT WAS ON THE OPPOSITE ARM THEN IT WAS MOVED TO THE SAME SIDE AS THE ACUMEN CUFF. REPLACING THE PRESSURE CONTROLLER FOR ANOTHER ONE RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

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.