BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 24112939 · Received January 20, 2026

    Report

    Report Number
    3001421318-2026-00027
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 3, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    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 REF NR: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: COMPLAINT DESCRIPTION: ¿EVENT OCCURED DURING PAITENT TRANSPORT FROM MSJ ED TO SPH ICU. PT WAS INTUBATED AND VENTILATED. ON ARRIVAL TO SPH THE VENTILATOR ALARMED "TURN FLOW SENSOR", VE DROPPED TO 0, AND ETCO2 ROSE TO 80MMHG. PLACED VENTILATOR ON STANDBY AND MANUALLY VENTILATED PT ON 15LPM. ETCO2 DECREASED TO ~60MMHG. PT TRANSPORTED FROM ENTRANCE OF SPH TO ICU MANUALLY VENTILATED.¿ THE AVAILABLE LOG DATA DOES NOT CONFIRM THE REPORTED ¿CHECK FLOW SENSOR / TUBING¿ MESSAGES, A ¿FLIP THE FLOW SENSOR¿ INDICATION, AN EXTERNAL FLOW SENSOR FAILED ALARM, OR A SWITCH INTO SENSOR FAILURE MODE, SO THE REPORTED EVENT CANNOT BE PROVEN FROM THE STORED RECORDS. WHAT IS CLEARLY VISIBLE IS THAT ON (B)(6) 2026 THE VENTILATOR FAILED THE FLOW SENSOR CALIBRATION FOUR TIMES BEFORE SUCCEEDING ON THE FIFTH ATTEMPT, WHICH INDICATES AN UNSTABLE OR BORDERLINE FLOW SENSOR CALIBRATION CONDITION AT THAT TIME. IN ADDITION, THE PRESSURE SENSOR GAIN VALUES ARE UNUSUALLY SPREAD (PVENT CONTROL 995, PVENT MONITOR 997, PAW 1011), WHICH SUGGESTS THE DEVICE WAS NOT OPTIMALLY CALIBRATED OR A SENSOR OR MEASUREMENT WAS DRIFTING. THE MOST LIKELY EXPLANATION IS A TEMPORARY MEASUREMENT INSTABILITY CAUSED BY AN INCORRECTLY CONNECTED OR IMPAIRED FLOW SENSOR SETUP (WRONG ORIENTATION, REVERSED/LOOSE CONNECTIONS, KINKED TUBES, OR LIQUID/CONDENSATION) OR A PNEUMATIC LEAK THAT AFFECTS CALIBRATION STABILITY. REPLACING THE EXPIRATORY VALVE ASSEMBLY IS CONSISTENT WITH ADDRESSING A LEAK-RELATED CONTRIBUTOR AND SOLVED THE ISSUE. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "T1 VENTILATOR THAT STOPPED VENTILATING DURING TRANSPORT. THE FULL DESCRIPTION OF THE EVENT FROM CLINICAL STAFF IS AS FOLLOWS: ¿EVENT OCCURED DURING PAITENT TRANSPORT FROM MSJ ED TO SPH ICU. PT WAS INTUBATED AND VENTILATED. ON ARRIVAL TO SPH THE VENTILATOR ALARMED "TURN FLOW SENSOR", VE DROPPED TO 0, AND ETCO2 ROSE TO 80MMHG. PLACED VENTILATOR ON STANDBY AND MANUALLY VENTILATED PT ON 15LPM. ETCO2 DECREASED TO ~60MMHG. PT TRANSPORTED FROM ENTRANCE OF SPH TO ICU MANUALLY VENTILATED.¿" NO HEALTH CONSEQUENCES OR IMPACT. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178068 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown