BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET, COAXIAL

    MDR report key: 25170330 · Received May 14, 2026

    Report

    Report Number
    3001421318-2026-00304
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 14, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    UDI-DI
    07630002802970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    IT WAS REPORTED TO HAMILTON MEDICAL AG THAT THE USER WAS ABOUT TO MOVE A PATIENT FROM A HAMILTON-C6 (PCV+) TO A HAMILTON-T1 (PCV+) FOR TRANSPORTATION. THEY WERE USING THE PN260167 CIRCUIT AND PERFORMED THE PREOPERATIONAL TESTS SUCCESSFULLY. WHEN SWITCHING VENTILATOR AND AFTER SOME BREATHS, THE HAMILTON-T1 ALARM EXPIRATION BLOCKED. THEY SWITCHED BACK TO HAMILTON-C6 AND REPLACED THE BREATHING CIRCUIT TO A NEW ONE FROM THE SAME LOT. SAME ISSUE. THEY REMOVED THE SINGLE USE EXPIRATORY VALVE AND MOUNTED THE REUSABLE ONE. THEY PERFORMED THE PREOPERATIONAL TESTS AND THEN MOVED THE PATIENT TO THE HAMILTON-T1 AND IT WORKED FINE. NO ALARMS. THE PATIENT WERE ABLE TO PROCEED WITH THE TRANSPORT. NO ADVERSE HEALTH CONSEQUENCES OR PATIENT IMPACT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553834 BREATHING CIRCUIT SET, COAXIAL BREATHING CIRCUIT SET, COAXIAL BZO HAMILTON MEDICAL AG 260167 203475 07630002802970

    Patients

    Seq Age Sex Outcome Treatment
    1