BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 24925350 · Received April 20, 2026

    Report

    Report Number
    3001421318-2026-00220
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    January 26, 2026
    Report Date
    April 20, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (B)(4). THE IMDRF ANNEX A CODE CHOSEN IS A0723 - UNEXPECTED MODE SWITCH. HOWEVER, THIS CODE CANNOT BE CHOSEN IN THE SYSTEM. THEREFORE, THE CODE "4076 - DEVICE IN BACKUP-MODE" WAS SELECTED. THIS REPORT ALSO INCLUDES THE INVESTIGATION RESULTS: ANALYSIS OF THE LOG FILES FOR HAMILTON-C1 VENTILATOR WITH SERIAL NUMBER (SN) (B)(6) CONFIRMED THE VENTILATION MODE SWITCHING FROM (S)CMV+ (VOLUME CONTROLLED) TO PCV+ (PRESSURE CONTROLLED) ON THE REPORTED EVENT DATE OF JANUARY 26, 2026. FURTHER ON, IT WAS RECORDED THAT THE FIRST VENTILATION MODE SWITCHING FROM (S)CMV+ (VOLUME CONTROLLED) TO PCV+ (PRESSURE CONTROLLED) OCCURRED ON (B)(6) 2026. ADDITIONALLY, MULTIPLE ALARMS AND ERRORS: HIGH MINUTE VOLUME, VT HIGH, CHECK CO2 AIRWAY ADAPTER, INSPIRATORY VOLUME LIMITATION, PETCO2 HIGH, DISCONNECTION ON PATIENT SIDE, MAXIMUM LEAK COMPENSATION - OCCURRED UNTIL 'EXTERNAL FLOW SENSOR FAILED' ALARM APPEARED. (B)(6) 2016/2026, 09:02:43/MODE /PCV+ => (S)CMV+, (B)(6) 2017/2026, 09:02:43/MODE /SENSOR FAILURE MODE VENTILATION ENDED, (B)(6) 2018/2026, 09:02:43/!!! /EXTERNAL FLOW SENSOR FAILED CONDITION REMOVED, (B)(6) 2019/2026, 09:02:43/!!! /CHECK FLOW SENSOR TUBING CONDITION REMOVED, (B)(6) 2020/2026 ,09:02:41/!!! /LOW MINUTE VOLUME CONDITION REMOVED,. (B)(6) 2021/2026, 09:02:40/!! /VT LOW CONDITION REMOVED THEREFORE, THE DEVICE SWITCHING TO PCV+ (PRESSURE CONTROLLED) IS EXPECTED IF THE DEVICE DETECTS ISSUES IN THE FLOW SENSOR MEASUREMENT. IT WAS CONFIRMED THAT FULL FUNCTIONAL TESTS, SOFTWARE TEST AND ELECTRICAL SAFETY TESTS HAVE BEEN PERFORMED AND ALL TESTS PASSED. HENCE, DEVICE OPERATES AS ITS INTENDED PERFORMANCE AND RETURNED TO SERVICE. THE CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026 THE HAMILTON-C1 VENTILATOR WITH SN (B)(6) SWITCHED FROM VOLUME CONTROL MODE TO PRESSURE CONTROL MODE-SET RATE NOT BEING DELIVERED, ALARMS NOT WHERE THEY WERE PREVIOUSLY SET. PATIENT INVOLVEMENT WAS REPORTED. HOWEVER, NO MEDICAL INTERVENTION AND NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167432 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1