Description of Event or Problem · 0
I PURCHASED A CVSHEALTH BRANDED "WRIST BLOOD PRESSURE MONITOR" FROM A CVS RETAIL LOCATION FOR RESEARCH EVALUATION PURPOSES. THE DEVICE WAS NEW IN PACKAGE. I INSTALLED FRESH BATTERIES PER THE INSTRUCTIONS AND FOLLOWED THE MANUFACTURER'S DIRECTIONS FOR USE. WHILE CALMLY SEATED INDOORS, I POSITIONED THE CUFF ON MY WRIST AS INSTRUCTED, KEPT MY ARM SUPPORTED AT APPROXIMATELY HEART LEVEL, REMAINED STILL, AND REFRAINED FROM TALKING. DURING A SINGLE SITTING/SESSION, I OBTAINED NINE CONSECUTIVE BLOOD PRESSURE MEASUREMENTS IN RAPID SUCCESSION (APPROXIMATELY 1¿2 MINUTES APART). THE RECORDED READINGS WERE: 123/64 113/70 191/114 140/65 126/64 129/64 155/84 171/102 131/66 HEART RATE DURING ALL MEASUREMENTS RANGED BETWEEN 60¿71 BPM AND WAS CONSISTENT WITH AN INDEPENDENT WEARABLE DEVICE (FITBIT), DIFFERING BY NO MORE THAN 1¿2 BPM. THERE WERE NO SYMPTOMS SUCH AS HEADACHE, DIZZINESS, CHEST PAIN, OR DISTRESS DURING THE SESSION. THE OBSERVED SYSTOLIC VARIABILITY RANGED FROM 113 MMHG TO 191 MMHG WITHIN MINUTES UNDER STABLE CONDITIONS. DIASTOLIC VALUES RANGED FROM 64 MMHG TO 114 MMHG. THIS MAGNITUDE OF INTRA-SESSION VARIABILITY OCCURRED WITHOUT CHANGES IN POSTURE, ACTIVITY, OR PHYSIOLOGICAL STATE. NO ERROR CODES WERE DISPLAYED. THE DEVICE APPEARED TO COMPLETE EACH MEASUREMENT NORMALLY. THERE IS A QA STICKER LOCATED ON THE DEVICE NEXT TO THE BATTERY ENCLOSURE COVERING A FASTENER. STORE ADDRESS (B)(6) PURCHASE DATE: (B)(6) 2026. DEVICE INFORMATION: LOT NUMBER 25021300304 SERIES 600 MODEL BP3KY1-3BCVS (B)(6) DISTRIBUTOR: (B)(4). (B)(6) COMPANY PHONE: (B)(6) MADE IN CHINA THE BOX INDICATES THAT THE DEVICE HAS CLINICALLY PROVEN ACCURACY, AND A LIMITED LIFETIME WARRANTY PURCHASING RECEIPT INFORMATION: REG#(B)(4) TRN#(B)(4) CSHR#(B)(4) STR#(B)(4), BARCODE NUMBER (B)(4).