BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21716683 · Received March 28, 2025

    Report

    Report Number
    3001421318-2025-00464
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 17, 2025
    Report Date
    February 13, 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 CASE NUMBER IS: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: IT WAS REPORTED THAT DURING PREPARATION FOR PATIENT TRANSPORT, THE CREW ATTEMPTED TO TRANSITION THE PATIENT FROM THE REFERRING FACILITY VENTILATOR TO A T1. PRIOR TO THE SWITCH, THE REFERRING VENTILATOR REPORTEDLY SHOWED VTE ~390¿410 ML WITH "PIP" (PEEP) 30¿41 CMH2O AND APPROPRIATE WAVEFORMS. MEDICAL COMMAND WAS CONTACTED REGARDING AN INTRINSIC PATIENT RATE OF 35 BPM AND SEVERE ACIDOSIS (PH REPORTED AS 6.95); CHEMICAL PARALYSIS WAS REQUESTED/INITIATED FOR TRANSPORT DUE TO PATIENT¿VENTILATOR DYSSYNCHRONY. THE CREW REPORTED VERIFYING T1 SETTINGS PRIOR TO CONNECTION (CMV-EQUIVALENT MODE, RR REPORTED AS 30, VT 420 ML, FIO2 100%, PEEP 18 CMH2O, ITIME 1.0 S). UPON APPLICATION OF THE DEVICE TO THE PATIENT, THE VENTILATOR REPORTEDLY DID NOT TRIGGER/ACTIVATE AND DID NOT DELIVER MECHANICAL BREATHS. THE CREW REPORTED THERE WERE NO AUDIBLE OR VISUAL INDICATORS SUGGESTING AN OPERATIONAL ISSUE, AND NO VOLUMES OR FLOW WAVEFORMS WERE IDENTIFIED ON THE DEVICE. THE DEVICE, ETT PLACEMENT, AND CIRCUIT WERE RE-EVALUATED AND NO ABNORMALITIES WERE IDENTIFIED. THE PATIENT WAS PLACED BACK ONTO THE REFERRING FACILITY VENTILATOR FOR CONTINUED SUPPORT WHILE TROUBLESHOOTING CONTINUED. DURING SUBSEQUENT EVALUATION, THE CREW REPORTED THAT IN CMV MODE THE ONLY ADJUSTABLE PARAMETER AVAILABLE WAS "ITIME" (NOT I:E RATIO), AND ITIME WAS REDUCED FROM 1.0 TO 0.9 SECONDS (PER BEDSIDE RT SUGGESTION) TO ALLOW MORE EXHALATION TIME. AFTER THIS CHANGE, THE CREW REPORTED OBSERVING EXHALED TIDAL VOLUME INCREASING TO ~240 ML AND A MINUTE VOLUME OF ~8.0 L/MIN FOR A SHORT PERIOD. THE CREW THEN PLACED THE PATIENT BACK ON THE REFERRING VENTILATOR WITH THE PREVIOUS SETTINGS. WHEN THE JS21 CREW ARRIVED, THEIR HAMILTON T1 WAS APPLIED AND REPORTEDLY DELIVERED APPROPRIATE VOLUMES WITH FLOW AND PRESSURE WAVEFORMS; TRANSPORT THEN PROCEEDED WITHOUT FURTHER REPORTED CHANGES IN PATIENT CONDITION. THERE WAS NO REPORT OF HARM TO PATIENT, USER OR THIRD PARTY, NOR A TREATMENT IN DELAY. THE COMPLAINT REPORT WAS EVALUATED BY A CLINICAL EXPERT; AND ADDITIONAL INFORMATION WAS REQUESTED BASED ON THIS EVALUATION; BUT THERE WAS NO RESPONSE FROM THE CUSTOMER AFTER THREE REQUESTS FOR ADDITIONAL INFORMATION IF REPLACING IT RESOLVED THE ISSUE. SERVICE FOLLOW-UP REPORTED THE DEVICE WAS POWER-CYCLED, SERVICE SOFTWARE WAS COMPLETED, AND THE DEVICE WAS RUN WITHOUT REPRODUCTION OF THE REPORTED ISSUE. THE DEVICE PASSED SERVICE TESTING AND NO FAULT COULD BE REPLICATED AT THAT TIME. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: QUOTATION FROM THE REPORTER: "CREW WAS PREPARING PATIENT FOR TRANSPORT. THE CREW NOTED PRIOR TO THE APPLICATION OF THE T1 THAT THE TVE=390-410 ON REFERRING FACILITY VENTILATOR AND PIP 30-41 WITH PROPER WAVEFORM APPEARANCE. MEDICAL COMMAND WAS CONTACTED AND ADVISED OF PATIENT INTRINSIC RATE AT 35 BPM AND FURTHER REQUESTED CHEMICAL PARALYSIS FOR TRANSPORT SECONDARY TO DESYNCHRONY (PATIENT WAS OVER BREATHING THE PRESCRIBED RATE MOST LIKELY DUE TO PH=6.95). THE SETTINGS WERE VERIFIED BY BOTH CREW MEMBERS; CMV (EQUIVALENT) RR=3-, TV=420, FI02=100, PEEP=18 ITIME=1.0 ON THE HAMILTON VENTILATOR. UPON APPLICATION OF THE HAMILTON T1 VENTILATOR TO THE PATIENT THE VENTILATOR DID NOT TRIGGER OR ACTIVATE. DURING THE INITIAL SET UP OF THE VENTILATOR THERE WERE NO AUDIBLE OR VISUAL INDICATORS TO ALERT THE CREW TO ANY OPERATIONAL ISSUES. THE VENTILATOR DID NOT INITIATE ANY MECHANICAL BREATHS AND THE PATIENT HAD BEEN CHEMICALLY PARALYZED ON THE TRANSPORT STRETCHER PRIOR SWITCHING FROM THE FACILITY VENTILATOR TO THE HAMILTON. NO VOLUMES OR FLOW WAVES WERE IDENTIFIED ON THE T1. THE HAMILTON T1, ETT PLACEMENT AND CIRCUITS WERE EVALUATED AGAIN WITHOUT ABNORMALITIES. THE PATIENT WAS PLACED BACK ON THE REFERRING FACILITY VENTILATOR FOR ADDITIONAL TROUBLESHOOTING. SETTINGS WERE AGAIN VERIFIED AND DURING THE EVALUATION THE CREW NOTED THAT THE ONLY SETTING THAT COULD HAVE BEEN CHANGED IN THE CMV MODE WAS TO ITIME AND NOT THE ABILITY TO CHANGE THE I: E RATIO (BASED ON INCREASED RR). AT THIS POINT THE CREW REDUCED THE ITIME FROM 1.0 TO 0.9 IN ORDER TO ALLOW FOR MORE EXHALATION TIME (AT THE SUGGESTION OF RESPIRATORY THERAPY AT THE BEDSIDE). THERE WAS THE PRESENCE OF INCREASING TVE THAT WAS INCREASING TO 240 ML, MV WAS NOTED TO BE 8.0L/MIN FOR A SHORT PERIOD AS THE CREW EXITED THE CATH LAB. THE CREW WENT TO ROOM 1 IN THE ED AND PLACED THE PATIENT BACK ON THE REFERRING VENTILATOR WITH THE PREVIOUS SETTINGS. UPON ARRIVAL OF THE JS21 CREW THEIR HAMILTON T1 WAS APPLIED AND WAS SUCCESSFUL IN DELIVERING THE APPROPRIATE VOLUMES WITH WAVEFORMS OF FLOW AND PRESSURE. AT THIS POINT PATIENT WAS CONFIRMED FOR TRANSPORT AND THE TRANSPORT ENSUED. DURING THE REMAINDER OF THE TRANSPORT NO FURTHER CHANGES OF THE PATIENT CONDITIONS OCCURRED." NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472248 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown