BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPIRATORY VALVE SET

    MDR report key: 25067960 · Received May 4, 2026

    Report

    Report Number
    3001421318-2026-00246
    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
    GM
    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: "THE BREATHING CIRCUIT SET WITH PN 260167 / SN (B)(6) PASSED ALL TESTS DURING THE DEVICE CHECK, BUT IMMEDIATELY AFTER CONNECTING TO THE PATIENT, AN EXPIRATORY STENOSIS OCCURRED AND VENTILATION WAS NOT POSSIBLE. A NEW SET WAS ATTACHED AND PASSED THE DEVICE TEST; HOWEVER, AFTER CONNECTING THE PATIENT, THE SAME ERROR MESSAGE APPEARED. ON THE THIRD ATTEMPT, A DIFFERENT BATCH WAS USED, THE TEST WAS PASSED, AND VENTILATION OF THE PATIENT WAS POSSIBLE WITHOUT ANY ISSUES." FOLLOW-UP PERFORMED FOR ADDITIONAL INFORMATION IN RELATION TO THE REPORTED EVENT CONFIRMED PATIENT INVOLVEMENT AND THAT THE PATIENT HAD EXPERIENCED A TEMPORARY LACK OF OXYGEN SUPPORT WITHOUT ANY SUBSEQUENT HEALTH IMPACT. A MEDICAL INTERVENTION IN THE FORM OF THE DEVICE BEING DISCONNECTED, AND AN ALTERNATIVE VENTILATOR HAVING BEEN USED UNTIL THE PATIENT WAS STABILIZED WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148536 EXPIRATORY VALVE SET EXPIRATORY VALVE SET BZO HAMILTON MEDICAL AG 260167 202498

    Patients

    Seq Age Sex Outcome Treatment
    1