BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 20106709 · Received August 30, 2024

    Report

    Report Number
    20106709
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 16, 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

    WHEN ATTACHING THE SPIROS TO THE END OF THE TUBING LINE, IT WOULD NOT CONNECT IT JUST KEPT SPINNING AND DID NOT MAKE THE CLICKING NOISE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315674 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. CH2000SC-10 13911928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other