BEUDAMED
    FDA Adverse Event Death Summary report: N

    IHEALTH CONTINUOUS MONITORING DEVICE

    MDR report key: 19151764 · Received April 19, 2024

    Report

    Report Number
    MW5154023
    Event Type
    Death
    Date Received
    April 19, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 17, 2024
    Manufacturer
    ANDON HEALTH CO., LTD
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT FOUND DECEASED IN HOME WEARING CONTINUOUS MONITORING DEVICE, MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593662 IHEALTH CONTINUOUS MONITORING DEVICE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN ANDON HEALTH CO., LTD BP5S

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death