BEUDAMED
    FDA Adverse Event Death Summary report: N

    IHEALTH_BP5S

    MDR report key: 19151705 · Received April 19, 2024

    Report

    Report Number
    MW5154021
    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. "(B)(6) HEALTH, (B)(6). SOFT HORSE FIVE AND ALERT DILL THREE. MANUFACTURER IS SAMSUNG: SOFT HORSE FIVE CURRENT_HEALTH_TABLET - (MANUFACTURER IS SAMSUNG). MANUFACTURER IS BEST BUY HEALTH, CURRENT HEALTH OF THE BELOW PRODUCTS: SOFT HORSE FIVE CURRENT_HEALTH_WEARABLE_V2. CURRENT_HEALTH_HOMEHUB ALERT DILL THREE. IHEALTH_BP5S." REFERENCE REPORTS: MW5154019, MW5154020, MW5154022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593649 IHEALTH_BP5S SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN ANDON HEALTH CO., LTD. BPSS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death CURRENT_HEALTH_HOMEHUB.| CURRENT_HEALTH_TABLET.| CURRENT_HEALTH_WEARABLE_V2.