BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET, COAXIAL

    MDR report key: 25092224 · Received May 6, 2026

    Report

    Report Number
    3001421318-2026-00239
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 29, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (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 260127 IS LISTED IN THE SAME PRODUCT FAMILY PER THE MANUFACTURER ¿S IFU, AND THEREFORE FALLS UNDER THE SAME FDA PRODUCT CLASSIFICATION. BATCH/LOT NUMBER WAS NOT PROVIDED; HENCE, SPECIFIC DEVICE IDENTIFICATION REMAINS INCOMPLETE AT THIS STAGE.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION, "(B)(6) FROM (B)(6) SHARED THAT SHE HAD BEEN IN CONTACT REGARDING AN EXPIRATORY VALVE OCCLUSION/OBSTRUCTION ALARM." A PATIENT WAS INVOLVED IN THE REPORTED EVENT. HOWEVER, NO HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REPORTED TO BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419982 BREATHING CIRCUIT SET, COAXIAL BREATHING CIRCUIT SET, COAXIAL BZO HAMILTON MEDICAL AG 260127

    Patients

    Seq Age Sex Outcome Treatment
    1