BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNEQT PULSE

    MDR report key: 21846250 · Received April 16, 2025

    Report

    Report Number
    3003741676-2025-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 21, 2025
    Report Date
    May 20, 2025
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING FEEDBACK,HAVE CONTACTED THE USER TO RETURN THE PRODUCT FOR CONFIRMATION,BUT WE HAVE NOT YET RECEIVED THE BLOOD PRESSURE MONITOR. CUSTOMER FEEDBACK"THE ARM WAS SQUEEZED BY BLOOD PRESSURE MONITOR CUFF, CAUSING BRUISING,THE USER IS ALREADY 82 YEARS OLD.",WE CONSIDER THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO MEDICAL INTERVENTION OR SERIOUS INJURY IF IT WERE TO OCCUR. IF MORE EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL BE FOLLOWED UP. ADDITIONAL CONTENT: AFTER RECEIVING THE DEVICE, THE MANUFACTURER CONDUCTS RELEVANT PERFORMANCE TESTS FOR RETURNED DEVICES, THE DEVICE (SN: (B)(6) MEETS THE SHIPPING INSPECTION REQUIREMENTS.PLEASE REFER TO THE ATTACHED FILE FOR SPECIFIC TESTING INFORMATION. THE CUSTOMER REPLIED ON (B)(6),"PROBLEM IS GONE, NO DOCTOR VISIT."

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING FEEDBACK, HAVE CONTACTED THE USER TO RETURN THE PRODUCT FOR CONFIRMATION, BUT WE HAVE NOT YET RECEIVED THE BLOOD PRESSURE MONITOR. CUSTOMER FEEDBACK"THE ARM WAS SQUEEZED BY BLOOD PRESSURE MONITOR CUFF, CAUSING BRUISING, THE USER IS ALREADY 82 YEARS OLD.", WE CONSIDER THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO MEDICAL INTERVENTION OR 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

    AN 82 YEAR OLD FEMALE PATIENT DEVELOPED A BRUISE ON HER LEFT ARM AFTER USING THE BPM1AT. HER SYSTOLIC BLOOD PRESSURE AROUND 170 HAS BEEN RECORDED TO BE AS HIGH AS 188/91.GIVEN THE PATIENT'S AGE,HAVE THE POTENTIAL RISK OF 'SERIOUS INJURY',WHICH REQUIRES FURTHER ASSESSMENT.

    Description of Event or Problem · 0

    I'M USING THE NEW DEVICE WITH THE NEW CUFF BUT TWO DAYS AGO I STARTED TO DEVELOP SOME PROBLEMS IN MY LEFT ARM PROBABLY DUE TO THE CUFF OR THE DEVICE THAT IS SENDING TOO MUCH PRESSURE FOR SENSITIVE PERSONS OR MAYBE DUE TO AGE, BUT WITH MY PAST DEVICES THAT I USED THEY NEVER CAUSED ME ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351010 CONNEQT PULSE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN ANDON HEALTH CO., LTD. BPM1AT

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female