BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-T1

    MDR report key: 20176191 · Received September 9, 2024

    Report

    Report Number
    3016723884-2024-00013
    Event Type
    Death
    Date Received
    September 9, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 9, 2024
    Manufacturer
    HAMILTON MEDCIAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAVE UNSUCCESSFULLY TRIED TO REACH END USER REGARDING DEVICE SERIAL NUMBER AND DETAILS AROUND THE EVENT.

    Description of Event or Problem · 0

    A. SUMMATION OF THE EVENT: AN ANESTHESIA PROVIDER IN A DEPLOYED SETTING WAS USING THE HAMILTON-T1 VENTILATOR WITH THE UPAC VAPORIZER IN A PULL-THROUGH CONFIGURATION. AT CASE COMPLETION, THE PROVIDER INCREASED THE DELIVERED OXYGEN (HIGH PRESSURE PORT ATTACHED TO A REGULATOR-LIMITED H-CYLINDER) TO 100%. IN QUICK SUCCESSION, THE VENTILATOR INCREASED AIR FLOW TO >(B)(4), AND DELIVERED UNCONTROLLED HIGH PRESSURE TO THE PATIENT VIA THE ENDOTRACHEAL TUBE IN SITU. THIS WAS FOLLOWED BY A COMPLETE FAILURE OF THE HAMILTON-T1 VENTILATOR AND UNREGULATED VENTILATOR SHUT-DOWN. DURING TEST LUNG EXPERIMENTS PEAK AIRWAY PRESSURES AS HIGH AS 80MMHG WERE NOTED IMMEDIATELY PRECEDING THE T1 FAILURE. B. CAUSATIVE ELEMENTS: THE HAMILTON-T1 USED WAS EQUIPPED WITH THE NBC-COMPATIBLE HEPA AIR FILTER (HAMILTON PART NUMBER 161705), INTENDED TO BE USED IN CONTAMINATED ENVIRONMENTS IN CONCERT WITH A STANDARD NATO NBC CARTRIDGE FILTER ATTACHED TO THE AIR INLET ON THE BACK OF THE HAMILTON-T1 (NBC FILTER ADAPTER INSTRUCTION FOR USE, REF (B)(4), HAMILTON MEDICAL). THIS HEPA FILTER IMPROVES REMOVAL OF NBC CONTAMINATES FROM THE TRANSPORT VENTILATOR'S DELIVERED BREATHS TO THE PATIENT. LIKELY, DUE TO THIS INCREASED FILTRATION (RESISTANCE TO AIR FLOW) WHEN COUPLED WITH THE INCREASED DEMAND OF THE VENTILATOR ATTEMPTING TO DELIVER THE SET 100% OXYGEN CONCENTRATION, AND THE MINIMAL BUT RELEVANT INHERENT FLOW RESISTANCE THROUGH THE UPAC, THIS CAUSED VENTILATOR TOTAL SYSTEM FAILURE AND PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329948 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDCIAL AG HAMILTON-T1 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death