BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 22661208 · Received July 30, 2025

    Report

    Report Number
    3003741676-2025-00003
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 12, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    DXN
    PMA / PMN Number
    K160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    1. CUSTOMER SHOWS THE ORDER DATE OF (B)(6) 2021, RECEIVED FEEDBACK THAT IT WAS USED FOR THE FIRST TIME ON (B)(6) 2025 AND CAUSED INJURY. 2.AFTER RECEIVING FEEDBACK, HAVE CONTACTED THE USER TO RETURN THE PRODUCT FOR CONFIRMATION, BUT WE HAVE NOT YET RECEIVED THE BLOOD PRESSURE MONITOR. 3.ACCORDING TO CUSTOMER FEEDBACK, THE CUFF DAMAGED THE ARM AND WENT TO SEE A DOCTOR. 4.AFTER CONFIRMING THE PHOTOS PROVIDED BY THE USER, IT HAS BEEN DETERMINED THAT THE USER HAS EXPERIENCED BRUISING AND PARTIAL SKIN DAMAGE, THEREFORE THIS REPORT IS SUBMITTED 5.IF MORE EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL BE FOLLOWED UP.

    Additional Manufacturer Narrative · 0

    1.AFTER MULTIPLE FOLLOW-UPS, UNABLE TO PROVIDE THE COMPLAINT MACHINE. 2.SINCE THE EXACT CAUSE OF THE FEEDBACK PROBLEM CANNOT BE DETERMINED WITHOUT THE RETURN OF THE BPM AND CUFF IN QUESTION,ACCORDING TO THE CUSTOMER'S DESCRIPTION AND INJURY PICTURES,THROUGH ANALYSIS OF DESIGN SELF INSPECTION, RISK DOCUMENTS, USABILITY, AND OTHER ASPECTS,SPECULATION THAT THE REPORTED EVENT IS CONSISTENT WITH ABNORMAL CUFF APPLICATION OR MISUSE RATHER THAN AN EXPECTED OUTCOME UNDER CORRECT USE. 3.THE DEVICE SOFTWARE INCORPORATES REDUNDANT SAFETY CONTROLS, AND THESE CONTROLS HAVE BEEN VERIFIED THROUGH SOFTWARE VALIDATION AND SYSTEM TESTING,INCLUDING: A) MANUAL STOP AT ANY TIME DURING A MEASUREMENT, IF THE USER PRESSES THE STOP BUTTON, THE SYSTEM WILL IMMEDIATELY STOP THE MEASUREMENT AND DEFLATE THE CUFF. THIS MANUAL OVERRIDE RESPONDS IN ALL OPERATIONAL STATES. B) MAXIMUM CUFF PRESSURE IF SYSTEM PRESSURE EXCEEDS 300 MMHG, THE SOFTWARE WILL IMMEDIATELY TRIGGER AN ERROR STATE, STOP MEASUREMENT, AND AUTOMATICALLY DEFLATE THE CUFF. C) CONTINUOUS CUFF PRESSURE IF SYSTEM PRESSURE REMAINS ABOVE 15 MMHG CONTINUOUSLY FOR MORE THAN 3 MINUTES, THE SOFTWARE WILL TRIGGER AN ERROR STATE, STOP MEASUREMENT, AND AUTOMATICALLY DEFLATE THE CUFF. 4.THE PRODUCT HAS FULLY CONSIDERED AND CONTROLLED THE RELEVANT RISKS DURING THE DESIGN STAGE, AND THE PROBABILITY OF RISK OCCURRENCE IS ASSESSED TO BE EXTREMELY LOW.

    Description of Event or Problem · 0

    CUSTOMER SAID THEIR BLOOD PRESSURE MONITOR RIPPED THEIR SKIN. SHE HAS OWNED THIS DEVICE FOR A WHILE, BUT IT'S HER FIRST TIME USING IT. THE DAMAGE TO THEIR SKIN WAS CAUSED BY THE VELCRO ON THE BLOOD PRESSURE MONITOR.

    Description of Event or Problem · 0

    CUSTOMER SAID THEIR BLOOD PRESSURE MONITOR RIPPED THEIR SKIN. SHE HAS OWNED THIS DEVICE FOR A WHILE, BUT IT'S HER FIRST TIME USING IT. THE DAMAGE TO THEIR SKIN WAS CAUSED BY THE VELCRO ON THE BLOOD PRESSURE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41102 IHEALTH SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN ANDON HEALTH CO., LTD. KN-550BT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown