BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPIRATORY VALVE SET

    MDR report key: 25065261 · Received May 4, 2026

    Report

    Report Number
    3001421318-2026-00247
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 4, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    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: ¿WHEN CONNECTED TO THE PATIENT ON (B)(6) 2026, THE BREATHING CIRCUIT WITH PN 260128 / LN 202171 HAS AN "EXHALATION OBSTRUCTION" WHICH PREVENTS THE PATIENT FROM BREATHING OUT. THE VENTILATOR ALARMS IMMEDIATELY.¿ PATIENT INVOLVEMENT WAS REPORTED AND MEDICAL INTERVENTION WAS NEEDED, HOWEVER, NO FURTHER DETAILS ON THE MEDICAL INTERVENTION PERFORMED WERE PROVIDED. FURTHER, NO PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307656 EXPIRATORY VALVE SET EXPIRATORY VALVE SET BZO HAMILTON MEDICAL AG 260128 202171

    Patients

    Seq Age Sex Outcome Treatment
    1