BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET, COAXIAL

    MDR report key: 25134960 · Received May 11, 2026

    Report

    Report Number
    3001421318-2026-00287
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 11, 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. THE INITIAL USER REPORT CONTAINS MULTIPLE LOT NUMBERS IN A SINGLE REPORT. HAMILTON MEDICAL AG HAS CREATED AND SUBMITTED FOR EACH LOT NUMBER - ONE MDR. MANUFACTURER'S REFERENCE NUMBERS (LINKED TO HMAG REF: (B)(4) LISTED BELOW: (B)(4) AT THE TIME OF REPORTING, THE PRODUCTION DATE AND EXPIRATION DATE ARE NOT AVAILABLE, THEREFORE, COMPLETE UDI INFORMATION COULD NOT BE PROVIDED. ALL AVAILABLE DEVICE IDENTIFICATION INFORMATION HAS BEEN INCLUDED IN THIS REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A FOLLOW-UP SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: WHEN REPLACING THE BREATHING CIRCUIT ON THE HAMILTON-T1 VENTILATOR WITH THE TUBING FROM THE COAXIAL BREATHING CIRCUIT KIT EQUIPPED WITH A FLOW SENSOR AND AN EXHALATION VALVE (REF. 260167), THE ¿EXHALATION OBSTRUCTED¿ ALARM MESSAGE APPEARS AND PERSISTS. THESE INCIDENTS HAVE BEEN OCCURRING SEVERAL TIMES A DAY FOR THE PAST TWO MONTHS, AND THE AFFECTED BATCHES ARE AS FOLLOWS: 203019, 202496, 202490, 202168, 203019, 202473. A PROBLEM WITH THE EXHALATION VALVE IS SUSPECTED. HAMILTON HAS BEEN INFORMED. NO SERIOUS CONSEQUENCES HAVE BEEN OBSERVED IN PATIENTS. POSSIBLE CONSEQUENCES: DELAY IN TREATMENT AND/OR RISK OF INSUFFICIENT VENTILATION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525368 BREATHING CIRCUIT SET, COAXIAL BREATHING CIRCUIT SET, COAXIAL BZO HAMILTON MEDICAL AG 260167 203019

    Patients

    Seq Age Sex Outcome Treatment
    1