BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET, COAXIAL

    MDR report key: 24517338 · Received March 5, 2026

    Report

    Report Number
    3001421318-2026-00107
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 8, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    UDI-DI
    17630002802977
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE BREATHING SET (REF. (B)(4) WAS REPLACED WITH A NEW BREATHING SET (REF. (B)(4), LOT 202153). FOLLOWING REPLACEMENT, THE DEVICE SUCCESSFULLY PASSED THE PRE-OPERATIONAL CHECKS, INCLUDING FLOW SENSOR CALIBRATION AND TIGHTNESS CHECK. THE DEVICE WAS SUBSEQUENTLY CONNECTED TO A PATIENT AND VENTILATION WAS INITIATED IN PCV+ MODE. SHORTLY AFTER THE START OF VENTILATION, THE DEVICE GENERATED THE ALARMS ¿HIGH PEEP¿ AND ¿EXHALATION OBSTRUCTED.¿ THE PATIENT WAS MANUALLY VENTILATED (HAND BAGGED) UNTIL THE BREATHING SET WAS REPLACED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150390 BREATHING CIRCUIT SET, COAXIAL BREATHING CIRCUIT SET, COAXIAL BZO HAMILTON MEDICAL AG 260167 202153 17630002802977

    Patients

    Seq Age Sex Outcome Treatment
    1