BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET, COAXIAL

    MDR report key: 25083858 · Received May 5, 2026

    Report

    Report Number
    3001421318-2026-00259
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 5, 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 260128 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: "DURING AN EMERGENCY MEDICAL SERVICE (EMS) INTERVENTION, THE VENTILATOR WAS USED WITH A BREATHING CIRCUIT (REF 260128, LOT 202508) ON AN INTUBATED PATIENT. IT WAS OBSERVED THAT THE TIDAL VOLUMES WERE NOT BEING DELIVERED CORRECTLY. MANUAL BAG-VALVE-MASK VENTILATION WAS REQUIRED. A MALFUNCTION OF THE EXPIRATORY VALVE IN THE BREATHING CIRCUIT IS SUSPECTED. THIS TYPE OF PROBLEM IS ALREADY KNOWN TO AFFECT SEVERAL BATCHES OF REF 260167 BREATHING CIRCUITS AND HAS BEEN REPORTED BEFORE. CONFIRMED SERIOUS CONSEQUENCES: SWITCH TO MANUAL VENTILATION" THE PATIENT WAS MANUALLY VENTILATED USING A BAG-VALVE-MASK. NO PATIENT HARM, HEALTH IMPACT, OR ADVERSE CLINICAL CONSEQUENCES TO THE PATIENT, USER, OR THIRD PARTY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181706 BREATHING CIRCUIT SET, COAXIAL BREATHING CIRCUIT SET, COAXIAL BZO HAMILTON MEDICAL AG 260128 202508

    Patients

    Seq Age Sex Outcome Treatment
    1