BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECG+

    MDR report key: 22874226 · Received August 22, 2025

    Report

    Report Number
    3012267350-2025-00003
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Report Date
    August 22, 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 ORIGINAL COMPLAINT WAS THAT THE DEVICE WILL NOT TURN ON, EVEN AFTER BATTERY REPLACEMENT. ONCE THE DEVICE WAS RECEIVED FROM THE USER, THE BATTERIES WERE TESTED AND FOUND TO BE FULLY DEPLETED. THEREFORE, THE DEVICE WOULD NOT TURN ON. ONCE THE BATTERIES WERE REPLACED, THE DEVICE TURNED ON BUT WAS FOUND TO BE AUTOMATICALLY SCANNING, WITHOUT CONTACT TO THE ELECTRODES. IT APPEARED THAT THERE WAS A SWITCH UNDER THE ELECTRODES THAT WAS BEING PRESSED DOWN ON WHICH ALLOWED FOR THE FULL SCAN TO TAKE PLACE AND THEN POWER OFF. THE DEVICE WAS OPENED FOR A FIRMWARE UPDATE AND AFTER UPDATING, THE DEVICE WAS FUNCTIONING AS INTENDED. OPENING THE DEVICE APPEARED TO LIFT THE SWITCH THAT WAS BEING PRESSED AND THE DEVICE WAS NO LONGER AUTO-SCANNING.

    Description of Event or Problem · 0

    THE DEVICE WILL NOT TURN ON, EVEN AFTER BATTERY REPLACEMENT. THE DEVICE REQUIRES TWO AA BATTERIES TO FUNCTION. UPON FURTHER EVALUATION OF THE DEVICE, BOTH AA BATTERIES WERE DEPLETED. HOWEVER, ONCE THE BATTERIES WERE REPLACED, THE DEVICE WAS FOUND TO BE AUTOMATICALLY SCANNING - THE DEVICE WOULD INITIATE AND CONTINUE A SCAN WITHOUT PATIENT ELECTRODE CONTACT FROM THE USER, COMPLETE THE SCAN, AND POWER OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558487 HOMECG+ TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE DXH LOHMAN TECHNOLOGIES, LLC 2.0 2021 - 168283 0086003939734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female