BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 19891962 · Received August 2, 2024

    Report

    Report Number
    19891962
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    KRB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDIAC OUTPUT CABLE BREAKS WITH MINIMAL USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913537 ICU MEDICAL PROBE, THERMODILUTION KRB ICU MEDICAL, INC. 41422-42

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female