BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITORING ELECTRODES

    MDR report key: 21761837 · Received April 3, 2025

    Report

    Report Number
    MW5168527
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Report Date
    March 31, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONGOING CONCERN WITH THE SNAP CONNECTOR PIECE OF THESE ELECTRODE PATCHES TEARING AWAY UPON REMOVAL FROM PATIENT. SNAP CONNECTOR HAS TO BE MANUALLY PRIED OUT OF LEADS. NO CONNECTIVITY CONCERNS AND NO PATIENT HARM REPORTED. THIS HAS BEEN NOTED WITH CARDINAL HEALTH ELECTRODES FROM TWO LOTS HCE4H008 EXPIRATION 2027-08-08, AND HCE4K026 EXPIRATION 2027-11-28. REF REPORT: MW5168528.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372162 MONITORING ELECTRODES ELECTRODE, ELECTROCARDIOGRAPH DRX CARDINAL HEALTH 200, LLC HCE4H008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other