BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 20106677 · Received August 30, 2024

    Report

    Report Number
    20106677
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SPIROS DID NOT CONNECT TO REGULAR TUBING, DID NOT REACH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356430 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. CH2000SC-10 13890167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other