BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 24567789 · Received March 11, 2026

    Report

    Report Number
    3001421318-2026-00123
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 11, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REFERENCE: (B)(4). HAMILTON MEDICAL AGS CONCLUSION: INVESTIGATION IS ONGOING. NOTE: UDI NUMBER AND ALL RELATED DATA TO THE SERIAL NUMBER OF THE AFFECTED HAMILTON-T1 COULD NOT PROVIDED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED A REPORT THAT A HAMILTON-T1 VENTILATOR STOPPED VENTILATION OR WAS UNABLE TO PROVIDE VENTILATION DURING A SURGICAL PROCEDURE. TESTING SHOWED THAT THE DIAPHRAGM OF THE EXPIRATORY VALVE OPENED ONLY AT APPROXIMATELY 20 MBAR, PREVENTING PROPER VENTILATION. A SECOND SIMILAR OCCURRENCE INVOLVING A BREATHING SET FROM A DIFFERENT LOT HAD PREVIOUSLY BEEN REPORTED. VENTILATION WAS SAFELY MAINTAINED USING AN ALTERNATIVE METHOD, AND NO HARM OR HEALTH IMPACT OCCURRED. THE AFFECTED BREATHING CIRCUIT (PRODUCT NUMBER 260167, LOT NUMBER 203019) WAS REPLACED WITH A NEW ONE. THE CASE WAS REPORTED BY THE HOSPITAL TO THE LOCAL AUTHORITY (SWISSMEDIC, REFERENCE (B)(4)). THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628932 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown