BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    72 ADULT UNI-LIM COAXIAL ANESTHESIA CIRCUIT

    MDR report key: 11854843 · Received May 20, 2021

    Report

    Report Number
    11854843
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 12, 2021
    Manufacturer
    WESTMED, INC.
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS INDUCED AND INTUBATED WITHOUT INCIDENT WITH A WESTMED 72' ADULT UNI-LIM¿ COAXIAL ANESTHESIA CIRCUIT. ANESTHESIA WAS UNABLE TO VENTILATE THE PATIENT. UPON INSPECTION, AFTER THE CONCLUSION OF THE CASE, THE INSPIRATORY (INNER) LIMB OF THE CIRCUIT WAS NOTED TO BE TORTUROUS WITH A LIMITED DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755691 72 ADULT UNI-LIM COAXIAL ANESTHESIA CIRCUIT FILTER, BACTERIAL, BREATHING-CIRCUIT CAH WESTMED, INC. 9128 121420T52

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA Other