BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET, COAXIAL

    MDR report key: 25064792 · Received May 4, 2026

    Report

    Report Number
    3001421318-2026-00249
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 4, 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 AG 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

    IT WAS REPORTED TO HAMILTON MEDICAL AG THAT THE INCIDENT OCCURRED ON 7TH OF APRIL 2026 AND: "THE VENTILATION TUBE SYSTEM PASSED ALL TESTS. SUBSEQUENTLY, DURING VENTILATION, VENTILATION SUDDENLY BECAME IMPOSSIBLE. ALARM MESSAGE: ¿EXHALATION OBSTRUCTED¿. SWITCHED TO A MANUAL RESUSCITATION BAG. THIS PREVENTED HARM TO THE PATIENT. THIS IS A REPEAT INCIDENT, HENCE IT HAS BEEN RECORDED AGAIN." IT WAS REPORTED THAT THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189788 BREATHING CIRCUIT SET, COAXIAL BREATHING CIRCUIT SET, COAXIAL BZO HAMILTON MEDICAL AG 260167 203019

    Patients

    Seq Age Sex Outcome Treatment
    1