BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELADOC BLOOD PRESSURE MONITOR

    MDR report key: 23552938 · Received November 14, 2025

    Report

    Report Number
    3011196194-2025-00098
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 5, 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

    MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT WITH NO SUCCESS. 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 VIA EMAIL THAT THEIR BLOOD PRESSURE MONITOR NO LONGER WORKS SINCE THE BATTERIES EXPANDED, LIKELY CAUSING A THERMAL EVENT. MULTIPLE ATTEMPTS TO CONTACT THE MEMBER TO CONFIRM WHETHER ANY TREATMENT WAS PERFORMED DUE TO THE THERMAL EMAIL, BUT THE ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118913 TELADOC BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown