BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECG+

    MDR report key: 23791388 · Received December 12, 2025

    Report

    Report Number
    3012267350-2025-00017
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Report Date
    December 12, 2025
    Manufacturer
    LOHMAN TECHNOLOGIES, LLC
    Product Code
    DXH
    UDI-DI
    00860003939734
    PMA / PMN Number
    K052767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS UNABLE TO START A READING DUE TO THE SPRING CONTACTS NOT MAKING CONTACT WITH THE ELECTRODES.

    Description of Event or Problem · 0

    THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND TURNS OFF DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770495 HOMECG+ TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE DXH LOHMAN TECHNOLOGIES, LLC V2.0 00860003939734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown