BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 21846525 · Received April 16, 2025

    Report

    Report Number
    3003741676-2023-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    July 13, 2023
    Report Date
    September 6, 2023
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.USER DID NOT SPECIFY THE WORKING CONDITION WHEN CAUSING A BRUISE. THE CUSTOMER PROVIDED THE CIRCUMFERENCE OF HER ARM AS 16" OR 40.64CM, WHICH IS IN THE RANGE OF THE PROVIDED CUFF 22-42CM. THE USER'S ARM CIRCUMFERENCE IS NORMAL AND CAN BE MEASURED WITH A STANDARD CUFF. 2.REVIEW THAT THE DHR AND DMR OF THIS BATCH MET THE SPECIFIED REQUIREMENTS WITH NO PERFORMANCE ISSUES. 3.THE IHEALTH RECEIVED THE MALFUNCTIONING DEVICE TESTED THE DEVICE O 7 TIMES WERE UNABLE TO REPLICATE THE MALFUNCTION.THE DEVICE HAD ONE MEASUREMENT IN MEMORY WHEN IT WAS RECEIVED, SO I CAN ASSUME THAT THE DEVICE HAD COMPLETED AT LEAST THAT CYCLE. 4.WITH HIGH PRESSURE, PRESSURE WILL ALSO BE HIGH. OUR MAXIMUM INCREASE TO 295 MMHG WILL STOP PRESSURIZATION, PROTECT AND NOT OVERCHARGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED"WHEN I USED IT, IT CUT OFF CIRCULATION, TURNED MY HAND PURPLE, AND LEFT MULTIPLE BRUISES ON MY ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115711 IHEALTH System, measurement, blood-pressure, non-invasive DXN ANDON HEALTH CO., LTD. KN-550BT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown