BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECG+

    MDR report key: 22874328 · Received August 22, 2025

    Report

    Report Number
    3012267350-2025-00008
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Report Date
    August 21, 2025
    Manufacturer
    LOHMAN TECHNOLOGIES, LLC
    Product Code
    DXH
    UDI-DI
    0086003939734
    PMA / PMN Number
    K052767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATTERIES IN THE DEVICE WERE REPLACED AND TESTED. THE DEVICE WAS UPDATED TO THE LATEST FIRMWARE AND WAS FOUND TO BE FULLY FUNCTIONAL. UPON TESTING OF OTHER DEVICES WITH THE SAME ISSUE A MALFUNCTION WAS IDENTIFIED THAT PREVENTED THE DEVICE FROM TURNING ON WHEN THE BATTERIES WERE LOW, EVEN THOUGH THE REQUIRED VOLTAGE TO TURN THE DEVICE ON WAS MET.

    Description of Event or Problem · 0

    THE PATIENT REPORTS THAT THE DEVICE POWERS DOWN PRIOR TO OBTAINING A SUCCESSFUL SCAN. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656986 HOMECG+ TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE DXH LOHMAN TECHNOLOGIES, LLC V2.0 2023 - 171351 0086003939734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown