BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET

    MDR report key: 25316272 · Received May 28, 2026

    Report

    Report Number
    3001421318-2026-00323
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 28, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    UDI-DI
    07630002802963
    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 260128 IS LISTED IN THE SAME PRODUCT FAMILY PER THE MANUFACTURER ¿S IFU, AND THEREFORE FALLS UNDER THE SAME FDA PRODUCT CLASSIFICATION. HMAG REFERENCE NUMBER: (B)(4). FDA REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: A HAMILTON T1 VENTILATOR (PN 161009 / SN (B)(6) AND THE ASSOCIATED BREATHING CIRCUIT SET (PN 260128 / LN 202139) EXHIBITED A RECURRING ¿EXHALATION OBSTRUCTED¿ ALARM DURING INTERHOSPITAL TRANSPORT OF A TRACHEOTOMIZED PATIENT DESPITE CORRECT SETUP AND SUCCESSFUL COMPLETION OF ALL SYSTEM CHECKS. MULTIPLE TROUBLESHOOTING MEASURES, INCLUDING RECONNECTION OF THE BREATHING CIRCUIT, MEMBRANE INSPECTION, REPEATED SYSTEM TESTS, AND DEVICE RESTART ATTEMPTS, DID NOT RESOLVE THE ISSUE. THE PRESSURE CURVE INDICATED IMPAIRED EXHALATION, WHILE ALL SELF-TESTS SHOWED NORMAL FUNCTION. THE VENTILATOR HAD TO BE REPLACED, AFTER WHICH VENTILATION CONTINUED WITHOUT ISSUE. VENTILATION WITH AN ALTERNATIVE VENTILATOR (HAMILTON S1) WAS ALSO UNEVENTFUL, EXCLUDING PATIENT-RELATED CAUSES. PATIENT INVOLVEMENT AND MEDICAL INTERVENTION (TROUBLESHOOTING MEASURES AND REPLACEMENT OF THE VENTILATOR WITH AN ALTERNATIVE VENTILATOR) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349744 BREATHING CIRCUIT SET BREATHING CIRCUIT SET BZO HAMILTON MEDICAL AG 260128 202139 07630002802963

    Patients

    Seq Age Sex Outcome Treatment
    1