BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET

    MDR report key: 25277198 · Received May 26, 2026

    Report

    Report Number
    25277198
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    March 7, 2026
    Report Date
    May 14, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE ENROUTE TO THE OUTSIDE HOSPITAL, WE WERE SETTING UP THE VENTILATOR CIRCUIT. THE VIRAL FILTERS WERE NOT ATTACHING BETWEEN THE EXHALATION LIMB OF THE CIRCUIT AND THE EXHALATION VALVE WHERE THEY NORMALLY GO. WE NOTICED THAT THE ELBOW OF THE EXPIRATORY LIMB HAD AN INNER LUMEN THAT THE INSPIRATORY LIMB ELBOW DID NOT. WE CHECKED THE OTHER LARGE CIRCUIT IN THE TRUCK, AND IT DID NOT HAVE THIS EITHER. WE WERE ABLE TO ASSEMBLE THE CIRCUIT WITH THE FILTER AT THE PATIENT WYE, SO IT FILTERED BOTH THE INSPIRATORY AND EXPIRATORY LIMBS. WE WERE ALSO ABLE TO SETUP THE AEROGEN BETWEEN THE PATIENT AND FILTER, SO THE VENTILATOR WAS PROTECTED. WITH THIS CONFIGURATION, THE VENT DID PASS ALL PRE-OP CHECKS. IT WORKED AS INTENDED FOR THE PATIENT. AFTER WE COMPLETED THE TRANSFER, WE LOOKED AT A FEW MORE CIRCUITS WITH THE SAME REF (BUT DIFFERENT LOT) AND IDENTIFIED THAT THIS ONE PARTICULAR CIRCUIT HAD THE EXPIRATORY LIMB ELBOW FLIPPED. THE CIRCUIT WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417261 BREATHING CIRCUIT SET SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) BZO HAMILTON MEDICAL AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1