BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOPPLI BLOOD PRESSURE MONITOR BAND/SENSOR

    MDR report key: 20200354 · Received September 11, 2024

    Report

    Report Number
    MW5159505
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 6, 2024
    Manufacturer
    PYRAMES INC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    OUR MEDICAL DIRECTOR DID MESSAGE ME SAYING THAT IT WAS PICKING UP WELL (BLOOD PRESSURE MONITORING SIGNAL) THE ENTIRE TIME BUT THEY WERE CONCERNED IT WASN'T ACCURATE DURING A TIME OF POTENTIAL HYPOTENSION. THE INFANT'S HEART RATE WAS HIGH (189) AND THE CUFF PRESSURE WAS READING PRETTY LOW 34/18 (23) BUT THE BOPPLI WAS READING A NORMAL BLOOD PRESSURE OF 59/36 (46). THEY DO BELIEVE BASED ON THE CLINICAL EXAM OF THE PATIENT THAT HE WAS ACTUALLY HYPOTENSIVE AT THE TIME. REF REPORT: MW5159506.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505470 BOPPLI BLOOD PRESSURE MONITOR BAND/SENSOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN PYRAMES INC. 24011702

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention