BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

    MDR report key: 24876330 · Received April 14, 2026

    Report

    Report Number
    24876330
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ICU MEDICAL
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BREATHING CIRCUITS FOR THE ANESTHESIA MACHINE WITH THE LOT NUMBER #6130212 HAVE A LEAK VOLUME >1000ML WHEN RUNNING A CIRCUIT TEST. THE PATIENT WAS IN THE OPERATING ROOM AND ANESTHESIA INDUCTION WAS DELAYED FOR 15 MINUTES WHILE TROUBLESHOOTING THE ANESTHESIA MACHINE. MULTIPLE COMPONENTS OF THE ANESTHESIA MACHINE WERE CHANGED BEFORE IDENTIFYING THAT THE CIRCUIT WAS THE ISSUE CAUSING THE LEAK. ANESTHESIA TECH MANAGER PRESENT IN OR TO TROUBLESHOOT MACHINE AND ENSURE MACH 406 WAS FUNCTIONING PROPERLY BEFORE INDUCING ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107675 CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI ICU MEDICAL 6130212

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other