BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23725434 · Received December 5, 2025

    Report

    Report Number
    3001421318-2025-00950
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    October 24, 2025
    Report Date
    December 5, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). THE REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. UPON REVIEW OF THE LOGFILES, THE ISSUE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE DEVICE ALARMED WITH THE DISCONNECTION ON VENTILATOR SIDE ON THE DAY OF THE EVENT. THE EVENT OCCURRED DURING VENTILATION, HOWEVER, NO HARM TO THE PATIENT WAS REPORTED. 2025-10-24 09:20:52 DISCONNECTION ON VENTILATOR SIDE ALARMS (B)(6). 2025-10-24 09:20:29 HIGH TIDAL VOLUME ALARMS (B)(6). 2025-10-24 09:20:11 AUDIO PAUSED ON SPECIAL (B)(6). 2025-10-24 09:20:09 AUDIO PAUSED OFF SPECIAL (B)(6). 2025-10-24 09:20:00 AUDIO PAUSED ON SPECIAL (B)(6). 2025-10-24 09:19:02 DISCONNECTION ON VENTILATOR SIDE ALARMS (B)(6). FOLLOWING THE EVENT, DURING TROUBLESHOOTING TEST MODE 13, PPAT (PATIENT PRESSURE) AND PAW (AIRWAY PRESSURE) WERE NOT RUNNING IN TANDEM. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE INSPIRATORY VALVE. AFTER THE VALVE WAS REPLACED, THE DEVICE PASSED ALL FUNCTIONAL TESTS AND OPERATED AS INTENDED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE VENTILATION OF A PATIENT, THE DEVICE ALARMED WITH DISCONNECTION ON VENTILATOR SIDE. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853747 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown