BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE HR

    MDR report key: 10137912 · Received June 9, 2020

    Report

    Report Number
    MW5094917
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    April 1, 2020
    Report Date
    June 8, 2020
    Manufacturer
    WITHINGS, INC.
    Product Code
    DXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A WITHINGS PULSE HR DEVICE MADE IN (B)(6) THAT HAS TWO GREEN LED LIGHTS THAT DETECT BLOOD PULSING IN THE VEINS IN THE BACK OF MY WRIST TO MEASURE MY HEART RATE. ARE THESE LED LIGHTS REGULATED? HAVE THEY BEEN VERIFIED FOR SAFE USE? I HAVE "BURNS" ON BOTH MY WRISTS WHERE THE LED LIGHTS HAVE BEEN APPLIED 24/7 FOR MANY WEEKS. THE DEBATE HERE IS THE CAUSE OF THOSE BURNS, I SAY IT IS THE LED LIGHTS BECAUSE OF THE LOCALIZATION OF THE BURNS. OTHER FOLKS TELL ME IT IS A METAL ALLERGY IN WHICH CASE IT SHOULD BE MORE WIDESPREAD ON MY WRISTS, AND I HAVE NO KNOWN METAL ALLERGIES. WITHINGS SUGGESTED CLEANING WITH ALCOHOL DAILY, BUT THIS DID NOT STOP THE PROBLEM. I SUSPECT THE LEDS ARE EMITTING TOO STRONGLY THE PHOTONS NECESSARY TO DO THE TASK. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595698 PULSE HR TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE DXH WITHINGS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR