BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET, COAXIAL

    MDR report key: 25123666 · Received May 8, 2026

    Report

    Report Number
    3001421318-2026-00277
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 8, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL REF.: (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 260167 IS LISTED IN THE SAME PRODUCT FAMILY PER THE MANUFACTURER ¿S IFU, AND THEREFORE FALLS UNDER THE SAME FDA PRODUCT CLASSIFICATION. THE INITIAL MDR SUBMISSION (B)(4) INCLUDED MULTIPLE LOT NUMBERS WITHIN A SINGLE REPORT. A FOLLOW-UP REPORT HAS BEEN SUBMITTED TO CORRECT THE ORIGINAL MDR WITH RESPECT TO ONE LOT NUMBER. ADDITIONAL INITIAL MDRS ARE BEING SUBMITTED FOR THE REMAINING LOT NUMBERS TO IMPROVE DEVICE TRACEABILITY AND ENSURE CLEAR IDENTIFICATION OF AFFECTED DEVICES. HMAG REF.: (B)(4). HMAG REF.: (B)(4). HMAG REF.: (B)(4). THE DEVICE IS IDENTIFIED BY MODEL NUMBER 260167 AND LOT NUMBER 202168. AT THE TIME OF REPORTING, THE PRODUCTION DATE AND EXPIRATION DATE ARE NOT AVAILABLE, THEREFORE, COMPLETE UDI INFORMATION COULD NOT BE PROVIDED. ALL AVAILABLE DEVICE IDENTIFICATION INFORMATION HAS BEEN INCLUDED IN THIS REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A FOLLOW-UP SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG: "THE CUSTOMER REPORTS SEVERAL EXPIRATORY OBSTRUCTIONS ON DIFFERENT DEVICES WITHIN A RELATIVELY SHORT PERIOD OF TIME. THE CUSTOMER RELIES ON THE FACT THAT OUR DEVICES ARE FUNCTIONAL AND STABLE TO QUESTION THE CONDITION OF THE CONSUMABLES. ACCORDING TO THE PERSON IN CHARGE, THEY HAD 2 CASES YESTERDAY AND THREE CASES TODAY. NO MENTIONED EXHALATION OBSTRUCTED APPEARED QUITE QUICK AFTER START OF VENTILATION. HIGH PRIO ALARM "EXHALATION OBSTRUCTED" APPEARED. NO PATIENT HARM OCCURRED." NO HEALTH CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED. BASED ON THE PROVIDED INFORMATION, BREATHING CIRCUIT SETS WERE REPLACED AFTER VENTILATION STARTED. DEVICE: BREATHING CIRCUIT SET, COAXIAL, CATALOGUE #: 260167, LOT #: 202168.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138444 BREATHING CIRCUIT SET, COAXIAL BREATHING CIRCUIT SET, COAXIAL BZO HAMILTON MEDICAL AG 260167 202168

    Patients

    Seq Age Sex Outcome Treatment
    1