BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECG+

    MDR report key: 22874400 · Received August 22, 2025

    Report

    Report Number
    3012267350-2025-00012
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Report Date
    August 22, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE POWER BUTTON APPEARED TO BE STUCK, WHICH RESULTED IN THE "FACTORY RESET" AND DEAD BATTERIES, WHICH CAUSED THE DEVICE TO CONSTANTLY TURN ON, RESET, AND TURN OFF.

    Description of Event or Problem · 0

    THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND READS "FACTORY RESET" THEN SHUTS BACK OFF AFTER CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456154 HOMECG+ TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE DXH LOHMAN TECHNOLOGIES, LLC V2.0 2021 - 168283 00860003939734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown