BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUITS

    MDR report key: 24198461 · Received January 27, 2026

    Report

    Report Number
    MW5182897
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Report Date
    January 23, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, INC.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REJECTED BY (B)(6). I AM NOT SURE IF THE PROCODE IS CAI OR BZE. THE HOSPITAL IS HAVING ISSUES WITH LEAKY PATIENT CIRCUITS (USED WITH THE 980 VENTILATOR). "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258095 BREATHING CIRCUITS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE FISHER & PAYKEL HEALTHCARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown