BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET

    MDR report key: 25091197 · Received May 6, 2026

    Report

    Report Number
    3001421318-2026-00262
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 6, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    UDI-DI
    07630002802963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 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: "ON (B)(6) 2026 THE HAMILTON-T1 VENTILATOR AND BREATHING CIRCUIT SET WITH PN 260128 / LN 202171 SUCCESSFULLY PASSED THE REQUIRED PRE-OP SAFETY CHECKS. HOWEVER, UPON ATTEMPTING TO CONNECT IT TO A PATIENT, THE SYSTEM REPEATEDLY DISPLACED THE WARNING "EXHALATION OBSTRUCTED". NO OBVIOUS VISUAL ISSUE WITH THE PATIENT CIRCUIT OR PATIENT WERE IDENTIFIED." PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION IN THE FORM OF A NEW CIRCUIT BEING USED WERE REPORTED. NO PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564158 BREATHING CIRCUIT SET BREATHING CIRCUIT SET BZO HAMILTON MEDICAL AG 260128 202171 07630002802963

    Patients

    Seq Age Sex Outcome Treatment
    1