BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECG+

    MDR report key: 23043095 · Received September 12, 2025

    Report

    Report Number
    3012267350-2025-00014
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Report Date
    September 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 BATTERIES ON THE DEVICE WERE REPLACED AND TESTED. THE DEVICE TOOK A SCAN AND UPDATED THE TIME BUT THE SCAN WAS NOT UPLOADED TO THE CLOUD. THE DEVICE IS IN PROGRESS OF BEING UPDATED. 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 TURNS ON AND TURNS OFF AFTER A FEW SECONDS DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION FROM THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070586 HOMECG+ TRANSMITTERS AND RECEIVERS, ELECTROCARDIGRAPH, TELEPHONE DXH LOHMAN TECHNOLOGIES, LLC V2.0 2021 - 16828 00860003939734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown