BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET

    MDR report key: 25077672 · Received May 5, 2026

    Report

    Report Number
    3001421318-2026-00255
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 5, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    UDI-DI
    07630002802963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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: "ON (B)(6) 2026 THE BREATHING CIRCUIT SET WITH PN 260128 / LN 202499, FOLLOWING SURGICAL PROCEDURE COMPLETION, STAFF FROM THE ONIT UNIT (ICU) ARRIVED TO RETRIEVE THE PATIENT WITH THEIR EQUIPMENT. THE ANESTHESIOLOGIST CONNECTED THE INTUBATED PATIENT TO A HAMILTON PORTABLE MECHANICAL VENTILATOR, WHEREBY THE DEVICE BEGAN DISPLAYING AN ERROR "EXHALATION OBSTRUCTED" AND NOT ALLOWING THE PATIENT TO EXHALE FULLY. THE DEVICE WAS PRIOR TESTED AND DID NOT EXHIBIT ANY ABNORMALITIES. ANOTHER HAMILTON TRANSPORT VENTILATOR WAS USED FOR TRANSPORT WITHOUT ANY ISSUES." PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (UTILIZATION OF ANOTHER VENTILATOR DURING INTUBATION) WAS REPORTED. NO PATIENT, USER, OR THIRD-PARTY HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538192 BREATHING CIRCUIT SET BREATHING CIRCUIT SET BZO HAMILTON MEDICAL AG 260128 202499 07630002802963

    Patients

    Seq Age Sex Outcome Treatment
    1