BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 21846278 · Received April 16, 2025

    Report

    Report Number
    3003741676-2025-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    DXN
    PMA / PMN Number
    K160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.CUSTOMER CLAIMS BLOOD PRESSURE MONITOR IS "DANGEROUS" BECAUSE IT IS READING 20 POINTS HIGHER THAN READINGS TAKEN BY NURSES AND CARDIAC CARE SPECIALISTS,COMPARISON METHOD AND DATA UNKNOWN(INSTRUCTIONS NOTICE:BLOOD PRESSURE MEASUREMENTS DETERMINED BY THIS MONITOR ARE EQUIVALENT TO THOSE OBTAINED BY A TRAINED OBSERVER USING THE CUFF/STETHOSCOPE AUSCULTATION METHOD, WITHIN THE LIMITS PRESCRIBED BY THE AMERICAN NATIONAL STANDARD INSTITUTE, ELECTRONIC OR AUTOMATED SPHYGMOMANOMETERS.) 2.AFTER RECEIVING FEEDBACK, IHEALTH CONTACTED CUSTOMER FOR EXCHANGE, THE SAMPLE WAS REQUESTED FOR EVALUATION,BUT THE PRODUCT HAS NOT BEEN RETURNED YET. 3.REVIEW THE DMR AND DHR INVOLVED IN THE COMPLAINT BATCH TO ENSURE COMPLIANCE WITH REGULATORY REQUIREMENTS 4.CUSTOMER FEEDBACK"THE BLOOD PRESSURE MONITORING INFORMATION I HAVE BEEN SENDING TO MY CARE PROVIDER FOR MORE THAN A MONTH, ON WHICH THEY BASE MY PRESCRIPTION MEDICINE.",WE CONSIDER THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IF MORE EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL BE FOLLOWED UP.

    Description of Event or Problem · 0

    THE IHEALTH BLOOD PRESSURE MONITOR I PURCHASED FROM AMAZON ON 10/30 IS CONSISTENTLY READING MY BLOOD PRESSURE AS 20 POINTS HIGHER THAN IT ACTUALLY IS. THIS HAS BEEN CONFIRMED TO ME BY NURSES AND CARDIAC CARE SPECIALISTS. THIS IS, OF COURSE, VERY DANGEROUS. THE BLOOD PRESSURE MONITORING INFORMATION I HAVE BEEN SENDING TO MY CARE PROVIDER FOR MORE THAN A MONTH, ON WHICH THEY BASE MY PRESCRIPTION MEDICINE, HAS BEEN QUITE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350018 IHEALTH System, measurement, blood-pressure, non-invasive DXN ANDON HEALTH CO., LTD. KN-550BT 1100000988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown