BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITHINGS - BPW CONNECT AUTOMATIC BLOOD PRESSURE MONITOR - WHITE/GRAY

    MDR report key: 9569345 · Received January 8, 2020

    Report

    Report Number
    MW5092113
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    November 30, 2019
    Report Date
    January 6, 2019
    Manufacturer
    WITHINGS S. A.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED A WITHINGS - BPM CONNECT AUTOMATIC BLOOD PRESSURE MONITOR; MODEL WPM05-ALL-INTER. THE BLOOD PRESSURE READINGS COMPARED WITH THE READINGS AT MY CARDIOLOGIST ARE 20% OFF. I HAVE RAISED THE CONCERN WITH THE COMPANY AND ASK TO EXCHANGE FOR A NEW MACHINE. THEY ARE NOT WILLING TO CONSIDER THE EXCHANGE. HENCE, I AM RAISING THE ISSUE WITH THE FDA. IF THE MACHINE MISREADS THE BLOOD PRESSURE LEVELS TO THAT EXTENT, EITHER THE UNIT ITSELF IS A LEMON (WHICH I SUSPECT) OR THE MACHINE IS POORLY DESIGNED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29599 WITHINGS - BPW CONNECT AUTOMATIC BLOOD PRESSURE MONITOR - WHITE/GRAY SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN WITHINGS S. A. WPM05-ALL-INTER

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other