BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARETOUCH

    MDR report key: 17291955 · Received July 10, 2023

    Report

    Report Number
    3016774562-2023-01533
    Event Type
    Injury
    Date Received
    July 10, 2023
    Report Date
    July 10, 2023
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE. THE CUSTOMER EXPERIENCED GROSSLY INACCURATE READINGS. THEY RECEIVED NUMBERS THAT WERE IN A STROKE RANGE BUT WHEN TAKEN MANUALLY THEIR BLOOD PRESSURE LEVELS WERE NORMAL.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE """I PURCHASED THIS BECAUSE I TAKE BLOOD PRESSURES FROM PATIENTS ALL DAY LONG AND ONCE I GET HOME I'M TO LAZY TO TAKE MINE TOO, LOL. THIS MACHINE IS GROSSLY INACCURATE. I READ THE DIRECTIONS OF USE AND FOLLOWED THE INSTRUCTIONS. SEVERAL TIMES IT WAS INCORRECT. IT SAID MY PRESSURE WAS 253/168. I TOOK IT MANUALLY (WITH A CUFF AND A STETHOSCOPE) AND IT WAS ACTUALLY 109/56. WHAT A DIFFERENCE. 253/168 IS AT STROKE LEVEL, MOST PEOPLE WOULD CONTACT THEIR DOCTOR AND END UP MAKING A UNNECESSARY TRIP AND COPAY TO BE TOLD YOU'RE BLOOD PRESSURE IS ACTUALLY WITHIN NORMAL LIMITS. TAKING A BLOOD PRESSURE WITH A CUFF AND STETHOSCOPE IS ALWAYS ACCURATE AND THE GOLD STANDARD. IN MY NURSING PRACTICE I TAKE ALL BLOOD PRESSURES THAT WAY DUE TO THE ACCURACY. I MEDICATE ACCORDING TO THE PRESSURE SO IF I'D USED THIS BLOOD PRESSURE MACHINE AND IT SAID 200/100 THE PATIENT WOULD BE MEDICATED. THINK WHAT WOULD HAPPEN IF I WENT BY THIS INACCURATE MACHINE , MEDICATED THE PATIENT AND THE PRESSURE WAS ACTUALLY 110/55 ? DANGEROUS, THIS IS A MAJOR SAFETY ISSUE. TAKE THE TIME TO LEARN HOW TO TAKE YOUR BLOOD PRESSURE WITH A CUFF AND STETHOSCOPE, THAT IS MY RECOMMENDATION. IT IS SOOO SIMPLE A TEN YEAR OLD COULD DO IT. AS LONG AS YOUR EARS WORK THAT'S ALL THE SKILL YOU NEED. IF YOU DECIDE TO TRY DOING IT MANUALLY HERE IS AN OVERVIEW OF HOW TO DO IT. PLEASE TAKE THE TIME TO WATCH A YOUTUBE TUTORIAL AS WELL. THE BLOOD PRESSURE CUFF SHOULD BE WRAPPED AROUND YOUR UPPER ARM, JUST ABOVE THE CROOK OF THE INSIDE OF THE ELBOW. THERE IS USUALLY A ARROW ON THE CUFF. THE ARROW SHOULD BE POINTING AT THE MIDDLE OF THE INSIDE OF THE ELBOW . THE CUFF SHOULD BE SNUG, BUT NOT VERY TIGHT. YOU SHOULD BE ABLE TO FIT TWO FINGERS UNDER THE CUFF WITHOUT DIFFICULTY. THE STEEL VALVE ON THE BULB SHOULD BE CLOSED ALL THE WAY SO THE AIR IN THE CUFF DOESN'T ESCAPE WHILE YOU ARE PUMPING THE BULB. PUMP THE BLACK BULB UNTIL THE GAUGE IS AT 250-275. SLOWLY TURN THE STEEL VALVE OPEN SLIGHTLY. HAVE THE ROUND GAUGE (THAT'S WHERE YOU CAN SEE THE NUMBERS) IN YOUR SIGHT. THERE IS A CLIP ON THE BACK OF THE GAUGE SO YOU CAN CLIP IT ON THE CUFF TO WATCH THE NUMBERS. THE STETHOSCOPE SHOULD BE JUST UNDER THE CUFF AND JUST OVER THE CROOK OF THE ELBOW IN THE MIDDLE OF THE ELBOW. AS YOUR LETTING THE AIR OUT SLOWLY, LISTEN FOR A SOUND. IT SOUNDS ALMOST LIKE A BEEP AND IT'S THE ONLY SOUND YOU WILL HEAR SO IT'S EASY TO HEAR THE BEEPS. WATCH THE GAUGE THE WHOLE TIME. WHEN YOU HEAR THE FIRST BEEP, LOOK AT WHERE THE NEEDLE INSIDE THE GAUGE IS POINTING. THAT IS THE SYSTOLIC NUMBER WHICH IS THE TOP NUMBER OF A BLOOD PRESSURE. THAT SIGNIFIES THE PRESSURE OF THE HEART WHEN IT'S AT WORK. KEEP LISTENING AND WHEN YOU HEAR THE LAST BEEP, THAT'S THE DIASTOLIC NUMBER WHICH IS THE BOTTOM NUMBER. THAT SIGNIFIES THE HEART AT REST. SO THERE IS YOUR BLOOD PRESSURE. A FEW THINGS TO CONSIDER. IF YOU HAVE BEEN ACTIVE, SIT DOWN AND WAIT FOR A FEW MINUTES BEFORE YOU TAKE THE BLOOD PRESSURE. YOUR PULSE IS FASTER WHEN ACTIVE SO IF YOU TAKE IT RIGHT AWAY THE PRESSURE COULD BE A BIT HIGHER THAN IT ACTUALLY IS. JUST A COUPLE MINUTES SITTING STILL IS FINE. IF YOU ARE OVERWEIGHT AND HAVE LARGER ARMS YOU NEED A XL CUFF. IF YOU USE A STANDARD CUFF AND YOU HAVE A LARGER ARM YOUR PRESSURE COULD SHOW SLIGHTLY HIGHER THAN IT REALLY IS. DO NOT CROSS YOUR LEGS AT ALL WHILE YOU'RE TAKING THE TEST. KEEP YOUR FEET FLAT ON THE GROUND. YOU ABSOLUTELY DO NOT NEED A HIGH END STETHOSCOPE. I FOUND ONE VIA AMAZON FOR 6 BUCKS. IF YOU FIND A CHEAP "DISPOSABLE' STETHOSCOPE THAT'S FINE. YOU CAN USE IT EVERY TIME YOU NEED TO TAKE YOUR BLOOD PRESSURE. YOU DO NOT NEED TO THROW IT AWAY AFTER USING. DISPOSABLE STETHOSCOPES ARE DESIGNED FOR PEOPLE WITH INFECTIONS OR CONTAGIOUS DISEASES SO THE STETHOSCOPE IS ONLY USED FOR THAT PATIENT, WE DON'T USE A STETHOSCOPE THAT HAS BEEN USED ON A INFECTIOUS PATIENT FOR OTHER PATIENTS. SO AFTER THE PATIENT IS DISCHARGED THE STETHOSCOPE IS THROWN AWAY. BUT IT ACTUALLY CAN BE USED FOREVER. CAN'T THINK OF ANY OTHER TIPS. PLEASE DON'T BUY THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805114 CARETOUCH BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD PSW01

    Patients

    Seq Age Sex Outcome Treatment
    1 Female