BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23765645 · Received December 10, 2025

    Report

    Report Number
    3001421318-2025-00959
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 10, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002802208
    PMA / PMN Number
    K193228
    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 REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE ALARMED WITH DISCONNECTION ON VENTILATOR SIDE ALARMS DURING THE VENTILATION OF A PATIENT. THE PROVIDED LOGFILES CONFIRM THE REPORTED ISSUE AT THE DATE OF THE EVENT. 2025-11-24 11:31:51 PEEP/CPAP 5.0 CMH2O SETTING 301. 2025-11-24 11:31:51 VT 300 ML SETTING 315. 2025-11-24 11:31:51 RATE 15 B/MIN SETTING 314. 2025-11-24 11:31:51 VENTILATION MODE (S)CMV SETTING 224. 2025-11-24 11:31:42 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. 2025-11-24 11:31:21 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. 2025-11-24 11:31:06 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. 2025-11-24 11:30:06 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. 2025-11-24 11:29:42 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. 2025-11-24 11:28:27 AUDIO PAUSED ON SPECIAL 516. 2025-11-24 11:28:11 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. 2025-11-24 11:17:57 O2 ENRICHMENT 79 % SETTING 373. 2025-11-24 11:17:57 NEBULIZER DURATION 30 MIN SETTING 351. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE SERVO MODULE, WHICH WAS SUBSEQUENTLY REPLACED. FOLLOWING THE REPLACEMENT, THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878595 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown