BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUITS

    MDR report key: 24870159 · Received April 14, 2026

    Report

    Report Number
    3001421318-2026-00212
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 14, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL REFERENCE NUMBER: (B)(4). INVESTIGATION IS ONGOING. HAMILTON COAXIAL BREATHING CIRCUIT FAMILY DEVICES IN THIS PRODUCT LINE ARE CLASSIFIED UNDER PRODUCT CODE BZO. ¿SET, TUBING AND SUPPORT, VENTILATOR (WITH HARNESS). PART NUMBER 260167 IS LISTED IN THE SAME PRODUCT FAMILY PER THE MANUFACTURER¿S IFU, AND THEREFORE FALLS UNDER THE SAME FDA PRODUCT CLASSIFICATION.

    Description of Event or Problem · 0

    ACCORDING TO THE INCIDENT DESCRIPTION: "ALTHOUGH ALL TESTS HAD BEEN PASSED, THE PATIENT COULD NOT BE VENTILATED. AN ERROR MESSAGE APPEARED ON THE DEVICE (PEEP TOO HIGH, MINUTE VOLUME TOO LOW AND EXPIRATORY STENOSIS). TO PREVENT HARM TO THE PATIENT, VENTILATION WAS CONTINUED USING A MANUAL RESUSCITATION BAG AND THE TUBING SYSTEM WAS REPLACED. VENTILATION THEN RESUMED. " IT WAS REPORTED THAT NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126252 BREATHING CIRCUITS BREATHING CIRCUITS BZO HAMILTON MEDICAL AG 260167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown