BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP CONNECT

    MDR report key: 12159749 · Received July 12, 2021

    Report

    Report Number
    MW5102471
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 8, 2021
    Manufacturer
    WITHINGS S.A.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INACCURATE BP CLASSIFICATION. REPORTING 119/80 AS STAGE 1 AND 121/80 AS ELEVATED. WRONG ACCORDING TO NEW GUIDELINES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052622 BP CONNECT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN WITHINGS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR