BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE 500 DIGITAL STETHOSCOPE

    MDR report key: 20665385 · Received November 12, 2024

    Report

    Report Number
    3011651230-2024-00001
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Report Date
    October 14, 2024
    Manufacturer
    EKO HEALTH, INC.
    Product Code
    DQD
    UDI-DI
    00850010298160
    PMA / PMN Number
    K230111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCED DEVICE WAS FORWARDED TO AN INDEPENDENT LABORATORY FOR FURTHER INVESTIGATION. THE INVESTIGATION FOUND A SIGNIFICANT AMOUNT OF CHARRED FOREIGN MATERIALS WHICH HAVE BEEN IDENTIFIED AS CHLORINE, PHOSPHORUS, SODIUM, AND FLUORINE INSIDE THE PORT OF THE USB-C CONNECTOR. THESE FOREIGN MATERIALS WERE CONSISTENT WITH HOUSEHOLD CLEANING SOLUTIONS. VISUAL INSPECTION OF THE REFERENCED DEVICE FOUND BURN MARKS AROUND THE SHIELD. THE USB-C PORT DID NOT EXHIBIT ANY SIGNS OF OVERHEATING. HOWEVER, SOME BROWNISH RESIDUES WERE OBSERVED. NO SIGNS OR PIN DAMAGE OR ANOMALOUS HIGH DENSITY RESIDUES WERE OBSERVED ON THE PINS WITHIN THE USB-C PORT. THE REPORTED INCIDENT WAS MOST LIKELY CAUSED BY THE FOREIGN MATERIALS AS THEY WERE OBSERVED IN SEVERAL LOCATIONS WITH THE USB-C CONNECTOR WHICH MIGHT HAVE CONTRIBUTED TO ELECTROCHEMICAL METAL MIGRATION AND CAUSE FAULT BETWEEN THE POWER AND GND PINS. BASED ON THE INVESTIGATION FINDINGS, IT WAS DETERMINED THE REPORTED INCIDENT WAS ATTRIBUTED TO INADVERTENT CONTAMINATION OF THE USB-C PORT.

    Additional Manufacturer Narrative · 0

    CUSTOMER ITEM RETURNED WITH EKO SUPPLIED USB-C CHARGING CABLE AND A THIRD-PARTY LAX BRAND CHARGER ON (B)(6)2024. A PRELIMINARY INITIAL VISUAL EXAMINATION REVEALED THAT THE USB-C CABLE EXPERIENCED A THERMAL EVENT AND DEMONSTRATED TRACES OF MELTED PLASTIC. THE CORE 500 CHESTPIECE DID NOT EXHIBIT SIGNS OF BURNING/CHARRING/MELTING, AND THE CHESTPIECE APPEARS TO FUNCTION NORMALLY WITH A KNOWN-GOOD CHARGING CABLE. ALL THREE ITEMS HAVE BEEN FORWARDED TO AN EXTERNAL TEST LABORATORY (XPONENT) FOR SPECIALIZED ELECTRICAL COMPONENT EXAMINATION ((B)(6)2024). A SUPPLEMENTARY REPORT WILL BE SUBMITTED AT A LATER DATE ONCE THE INVESTIGATION RESULT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE REFERENCED DEVICE OVERHEATED AND THE USB-C CHARGING CABLE MELTED DURING CHARGING. NO DEATH OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658785 CORE 500 DIGITAL STETHOSCOPE CORE 500 DIGITAL STETHOSCOPE DQD EKO HEALTH, INC. COR500 00850010298160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other