BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 21846352 · Received April 16, 2025

    Report

    Report Number
    3003741676-2023-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    July 9, 2023
    Report Date
    August 23, 2023
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO OTHER DETAILED INFORMATION PROVIDED BY THE CUSTOMER AFTER MULTIPLE REQUESTS FOR INFORMATION. THERE WAS NO INFORMATION PROVIDED REGARDING THE LOT NUMBER, SERIAL NUMBER, BAD POSITION OR USE-METHOD OF THE DEVICE. THE INVESTIGATION WILL BE FOLLOWED UP.

    Description of Event or Problem · 0

    THE SITE/USER WAS NOTED TO HAVE REPORTED THROUGH AMAZON VIA ZENDESK ON, AS FOLLOWS: "THE MACHINE EXPLODED AND INJURED ME PLEASE REFUND PRODUCT WAS DEFECTED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351051 IHEALTH System, measurement, blood-pressure, non-invasive DXN ANDON HEALTH CO., LTD. KN-550BT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization