BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 21591449 · Received March 13, 2025

    Report

    Report Number
    3001421318-2025-00410
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    December 23, 2024
    Report Date
    February 20, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4) FOLLOW-UP 1: INVESTIGATION OUTCOME. IT WAS REPORTED THAT "VENTILATION WAS CANCELED DURING THE ASV MODE." THE PATIENT WAS MOVED TO ANOTHER VENTILATOR. NO HARM TO THE PATIENT WAS REPORTED. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. UPON REVIEW OF THE LOGFILES DISCONNECTION ALARMS COULD BE OBSERVED HOWEVER, THERE IS NO INDICATION THAT THE "VENTILATION CANCELED" PLEASE SEE BELOW AN EXTRACT FROM THE LOGFILES. 2024-12-23 11:22:27 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011, 2024-12-23 11:22:27 TURN THE FLOW SENSOR ALARMS 4008, 2024-12-23 11:22:27 HIGH PRESSURE ALARMS 5019, 2024-12-23 11:22:26 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2024-12-23 11:22:25 HIGH PRESSURE ALARMS 5019 2024-12-23 11:22:25 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011, 2024-12-23 11:22:24 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2024-12-23 11:22:23 HIGH PRESSURE ALARMS 5019, 2024-12-23 11:22:23 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011, 2024-12-23 11:22:22 ETS 25 % SETTING 319, 2024-12-23 11:22:22 P-TRIGGER 2.0 -CMH2O SETTING 303, 2024-12-23 11:22:22 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2024-12-23 11:22:21 HIGH PRESSURE ALARMS 5019, 2024-12-23 11:22:21 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011, 2024-12-23 11:22:20 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2024-12-23 11:22:19 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011, 2024-12-23 11:22:19 HIGH PRESSURE ALARMS 5019, 2024-12-23 11:22:18 DISCONNECTION ON PATIENT SIDE ALARMS 5010. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE SERVO MODULE. FOLLOWING THE REPLACEMENT OF THE COMPONENT, THE DEVICE WORKED AS INTENDED. HAMILTON MEDICAL AG CONSIDERS THIS CASE CLOSED. CORRECTED DATA: B3. DATE OF THE EVENT IS 23.12.2024.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "VENTILATION WAS CANCELED DURING THE ASV MODE." THE PATIENT WAS MOVED TO ANOTHER VENTILATOR. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884027 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown