BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-MR1

    MDR report key: 22505268 · Received July 15, 2025

    Report

    Report Number
    3001421318-2025-00693
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    July 1, 2025
    Report Date
    April 3, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813556
    PMA / PMN Number
    K153046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 1: INVESTIGATION OUTCOME. UPON REVIEWING THE DEVICE LOGS, IT WAS NOTED THAT VENTILATION WAS INITIATED IN (S)CMV+ MODE, BUT WITHIN LESS THAN FIVE SECONDS, THE VENTILATOR TRIGGERED ALARMS INDICATING A PATIENT-SIDE DISCONNECTION, LOW MINUTE VOLUME, AND LOW TIDAL VOLUME. ALTHOUGH THE DEVICE WAS SWITCHED TO STANDBY MULTIPLE TIMES IN ATTEMPT TO RESOLVE THE ISSUE AND PRE-OPERATION CHECKS WERE COMPLETED SUCCESSFULLY, THE ISSUE PERSISTED. EACH ATTEMPT TO RESTART VENTILATION RESULTED IN THE SAME DISCONNECTION ALARM WITHIN SECONDS. NOTABLY, THERE WERE NO ALARMS RELATED TO INSPIRATORY VOLUME LIMITATION OR PRESSURE LIMITATION IN THE DEVICE LOGS. THE DEVICE HAD LAST BEEN SERVICED IN AUGUST 2024. DEVICE SETTINGS AT THE TIME OF EVENT: 447/2025-07-01 06:38:52/CONTROL /VT => 400.0 ML. 453/2025-07-01 06:38:52/ALARM /VT (LOW) => 280.0 ML. 454/2025-07-01 06:38:52/ALARM /VT (HIGH) => 850.0 ML. 457/2025-07-01 06:38:52/ALARM /PLIMIT => 30 CMH2O. 458/2025-07-01 06:38:52/ALARM /PRESSURE (LOW) => 5 CMH2O. 459/2025-07-01 06:38:52/ALARM /PRESSURE (HIGH) => 40 CMH2O. 464/2025-07-01 06:38:52/MODE /STANDBY => (S)CMV+. THE LOCAL SERVICE ENGINEER TESTED THE DEVICE USING THREE DIFFERENT VENTILATION MODES THAT MAY HAVE BEEN IN USE AT THE TIME OF THE REPORTED EVENT. THE TESTS WERE PERFORMED USING A 1 L TEST LUNG. NO ISSUES WERE DETECTED DURING TESTING, AND THE DEVICE WAS CONFIRMED TO BE FUNCTIONING PROPERLY. THE REPORTED PROBLEM COULD NOT BE REPRODUCED. BASED ON THE AVAILABLE INFORMATION, THIS CASE IS CONSIDERED CLOSED

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: ACCORDING TO THE COMPLAINT, THE PRETESTS OF THE VENTILATOR PASSED. HOWEVER, WHEN THE VENTILATION WAS INITIATED ON PATIENT, THERE WAS NO VISIBLE SIGN OF CHEST MOVEMENT. RETURN TIDAL VOLUMES WERE 30-50ML WHEN THE VENTILATOR WAS SET AT 400ML. THE VENTILATOR WAS EXCHANGED, AND THE PATIENT HAD NORMAL CHEST MOVEMENT AND RETURN TIDAL VOLUMES WERE CORRECT. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581238 HAMILTON-MR1 HAMILTON-MR1 CBK HAMILTON MEDICAL AG 1610100 07630002813556

    Patients

    Seq Age Sex Outcome Treatment
    1