BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11936573 · Received June 3, 2021

    Report

    Report Number
    3012307300-2021-05477
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(4) MEMORIAL HOSPITAL IN (B)(4), HAS HAD THREE NDA ALARMS WITH THE LEGACY PLUS AND THE 21-7302-24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832646 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1