BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKO ELECTRONIC STETHOSCIPE SYSTEM

    MDR report key: 25124596 · Received May 8, 2026

    Report

    Report Number
    3011651230-2026-00001
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Report Date
    May 7, 2026
    Manufacturer
    EKO HEALTH, INC.
    Product Code
    DQD
    UDI-DI
    00850010298009
    PMA / PMN Number
    K200776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURN HAS BEEN REQUESTED. AT THE DATE OF THIS REPORT DEVICE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED WHILE CHARGING THEIR DEVICE THE DEVICE BECAME VERY HOT. THE DEVICE BECAME HOT TO THE POINT THE USER COULD NOT TOUCH THE DEVICE. FOLLOWING THE EVENT THE DEVICE WAS NO LONGER ABLE TO POWER ON. NO DEATH OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310556 EKO ELECTRONIC STETHOSCIPE SYSTEM EKO CORE DIGITAL ATTACHMENT DQD EKO HEALTH, INC. EKO CORE W206082001 00850010298009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other