Description of Event or Problem · 1
WELL AT HOME BLOOD PRESSURE NOT PROVIDING ACCURATE READING. THE DEVICE WAS READING THE SYSTOLIC BLOOD PRESSURE 20 TO 30 MM OF MERCURY HIGHER THAN THE ACTUAL READING. STAFF ARE UNSURE IF THE DEVICE WAS CHECKED FOR ACCURACY PRIOR PLACEMENT IN THE PATIENT'S HOME. STAFF BELIEVE THAT THE UNIT WAS CALIBRATED AT THE MANUFACTURER. THE DISCREPANCY WAS DISCOVERED DURING A HOME VISIT WHEN THE MANUAL BLOOD PRESSURE READINGS DID NOT CORRELATE WITH THE DEVICE. THE DEVICE HAD BEEN IN USE FOR >24 HOURS WHEN THE PROBLEM WAS FOUND.FURTHER TESTING AND TROUBLE SHOOTING BY THE WELL AT HOME COORDINATOR REVEALED THAT UNIT NEEDED TO BE REMOVED FROM PATIENT HOME AND SENT BACK TO COMPANY. UNIT REMOVED FROM PATIENT HOME. NEW UNIT CHECKED FOR ACCURACY AND PLACED IN PATIENT'S HOME TWO DAYS LATER.THERE WAS NO CHANGE TO THE PATIENT'S PLAN OF CARE AS A RESULT OF THIS EVENT. NO PATIENT HARM.THE DEVICE WAS RETURNED TO THE MANUFACTURER. THEY HAVE SINCE RETURNED THE DEVICE TO THE FACILITY FOR CONTINUED PATIENT USE. NO REPORT FROM THE MANUFACTURER WAS PROVIDED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TAKE BP.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.