BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELADOC BLOOD PRESSURE MONITOR

    MDR report key: 23732535 · Received December 5, 2025

    Report

    Report Number
    3011196194-2025-00105
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 15, 2025
    Report Date
    January 26, 2026
    Manufacturer
    TELADOC HEALTH, INC
    Product Code
    DXN
    PMA / PMN Number
    K202891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE RELATED TO THIS INCIDENT WAS RETURNED FOR INVESTIGATION. INTERNAL FUNCTIONAL TESTING WAS PERFORMED, AND NO FAILURES WERE DETECTED DURING FUNCTIONAL TESTING. THE INTERNAL INVESTIGATION CONFIRMED THE DEVICE WAS WORKING AS INTENDED.

    Additional Manufacturer Narrative · 0

    A REPLACEMENT BLOOD PRESSURE MONITOR WAS SENT. THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE IS RETURNED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR TELADOC BLOOD PRESSURE MONITOR MADE A POPPING SOUND AND BEGAN EMITTING SMOKE FROM THE BOTTOM OF THE DEVICE. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT AS A PART OF THE DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR TELADOC BLOOD PRESSURE MONITOR MADE A POPPING SOUND AND BEGAN EMITTING SMOKE FROM THE BOTTOM OF THE DEVICE. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT AS A PART OF THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108672 TELADOC BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Unknown