BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRIST BLOOD PRESSURE UNIT

    MDR report key: 15003646 · Received July 12, 2022

    Report

    Report Number
    MW5110834
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 17, 2022
    Report Date
    June 24, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE BLOOD PRESSURE METER STARTED DISPLAYING BOGUS VERY HIGH BLOOD PRESSURE READINGS AFTER WORKING FINE FOR WEEKS. THIS OCCURRED WHILE I WAS CAMPING AT 8800 FT. ELEVATION, MAYBE THE LOWER AIR PRESSURE TRIGGERED VERY HIGH READINGS ON THE DEVICE. THE BLOOD PRESSURE METER SUDDENLY STARTED INDICATING VERY HIGH READINGS NEVER SEEN BEFORE IN YEARS OF DAILY MONITORING. 151/105, 180/129,159/107, 163/117 WERE ACTUAL READINGS IT GAVE. I REALIZED THAT THEY WERE BOGUS, AND I GOT OUT MY OLD BP METER, AND IT SHOWED NORMAL RANGE,= 120/78. IT IS DANGEROUS BECAUSE IF I HAD INCREASED MY BP MEDICINE DOSE; I COULD HAVE FLATLINED MY BLOOD PRESSURE TO ZERO AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908864 WRIST BLOOD PRESSURE UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN MEDLINE INDUSTRIES, LP - NORTHFIELD MDS4003

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other BLOOD PRESSURE CUFF | LISINOPRIL | PRAVASTATIN | TRIAMCINOLINE