BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WPM05 - WITHINGS BPM CONNECT

    MDR report key: 18326391 · Received December 13, 2023

    Report

    Report Number
    MW5149246
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    December 11, 2023
    Report Date
    December 11, 2023
    Manufacturer
    WITHINGS
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WITHING WPM05 BPM CONNECT BLOOD PRESSURE CUFF CONSISTENTLY REPORTS SYSTOLIC READINGS THAT ARE APPROXIMATELY 20 POINT HIGH AND DIASTOLIC READINGS THAT ARE 10 POINTS HIGH - 10 TO 15% HIGH WHEN COMPARED WITH A READING TAKEN IN A DOCTOR¿S OFFICE AND DIRECTLY COMPARING A TRADITIONAL BLOOD PRESSURE TEST WITH THE WITHING CUFF. AN ONLINE SEARCH REVEALS THAT THERE ARE NUMEROUS COMPLAINTS ABOUT THIS DEVICE. NOTABLY THESE COMPLAINTS ALL COMPLAIN OF THE 10 - 15% HIGH READINGS INDICATING A PRODUCT CALIBRATION PROBLEM. A CHAT CONVERSATION ON (B)(6) 2023 BETWEEN 1 AND 2 PM EST RESULTED IN NO RESOLUTION WITH WITHING'S USING TACTICS OF TRY THIS AND TRY THAT. THE BP CUFF IS A SIMPLE CONCEPT AND SHOULD YIELD ACCURATE READINGS WHEN USED IN ACCORDANCE WITH THE USER INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262237 WPM05 - WITHINGS BPM CONNECT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN WITHINGS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other