BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECG+

    MDR report key: 23432868 · Received October 30, 2025

    Report

    Report Number
    3012267350-2025-00015
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Report Date
    October 30, 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

    THIS DEVICE IS UNABLE TO START A READING DUE TO THE SPRING CONTACTS UNDER THE ELECTRODES NOT MAKING CONTACT. THE SPRING HEIGHTS WILL BE FIXED TO THE APPROPRIATE HEIGHT REQUIRED.

    Description of Event or Problem · 0

    DEVICE DOES NOT COUNTDOWN. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702682 HOMECG+ TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE DXH LOHMAN TECHNOLOGIES, LLC V2.0 00860003939734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown