BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 19536582 · Received June 14, 2024

    Report

    Report Number
    19536582
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 4, 2024
    Manufacturer
    TELEFLEX, INC.
    Product Code
    BTT
    UDI-DI
    54026704728508
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RESPIRATORY THERAPIST (RT) RESPONDED TO VENT ALARMING. RT AND THE NURSE ASSESSED PATIENT AND EQUIPMENT. CLINICAL STAFF FOUND THE VENT CIRCUIT MELTED AND FUSED TOGETHER AND CREATED A 100% LEAK. AFTER RECOGNIZING THE ISSUE, CALLED A CHARGE RT AND CHANGED THE VENT AND THE CIRCUIT. ISSUE WAS SOLVED. HEATER HUMIDIFIER INVOLVED IN INCIDENT WAS A TRIAL NEPTUNE HEATER HUMIDIFIER AND CIRCUIT. AFTER INCIDENT, PATIENT WAS SWITCHED TO HOSPITAL-OWNED FISHER & PAYKEL HEATER HUMIDIFIER. BIOMEDICAL ENGINEERING INSPECTED THE EQUIPMENT. THE HEATER HUMIDIFIER APPEARS TO HAVE OVERHEATED THE INTERNAL WIRE OF BREATHING CIRCUIT. THIS CAUSED THE TUBING TO FUSE TOGETHER. VENTILATOR WAS ALSO INSPECTED, NO ISSUES FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369305 HUDSON RCI HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT TELEFLEX, INC. IPN927526 54026704728508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown