BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELADOC BLOOD PRESSURE MONITOR

    MDR report key: 22542627 · Received July 18, 2025

    Report

    Report Number
    3011196194-2025-00073
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 18, 2025
    Manufacturer
    TELADOC HEALTH, INC
    Product Code
    DXN
    PMA / PMN Number
    K202891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REPLACEMENT DEVICE WAS SENT TO THE PATIENT. 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 SPARKED A FEW TIMES AND THERE WAS A PUFF OF SMOKE. THE PATIENT CONFIRMED THAT THEY DID NOT SUSTAIN ANY TYPE OF INJURY AS A RESULT. THE PATIENT STATED THAT THEY OPENED THE BATTERY COMPARTMENT OF THEIR DEVICE AND SAW THAT THE BATTERIES WERE SWOLLEN AND CORRODED. THEY DID NOT ATTEMPT TO CHANGE THE BATTERIES AND JUST DISCARDED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400237 TELADOC BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown