BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDELLA HEART FAILURE SYSTEM

    MDR report key: 23479644 · Received November 5, 2025

    Report

    Report Number
    3013900541-2023-00001
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    December 15, 2023
    Report Date
    December 19, 2023
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    OEZ
    UDI-DI
    01234567891234
    PMA / PMN Number
    K123456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS IS A TEST SUBMISSION FOR ESUBMITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607258 CORDELLA HEART FAILURE SYSTEM BLOOD PRESSURE CUFF OEZ ENDOTRONIX, INC 01234567891234

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| H