BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23552551 · Received November 14, 2025

    Report

    Report Number
    3001421318-2025-00910
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 14, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. THE REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. THE MANUFACTURER HAS RECEIVED THE LOGFILES FOR ANALYSIS. ACCORDING TO THE LOGFILES, THE VENTILATOR TRIGGERED A 'VENTILATOR UNIT CONNECTION LOST' AND OTHER SEVERAL ALARMS. THEREFORE, THE LOG FILES CONFIRMED THE ISSUE. (B)(6) 2025 14:03:33, TF : 2438, TECH FAULT 2438; (B)(6) 2025 14:03:33, TF : 2450, TECH FAULT 2450; (B)(6) 2025 14:03:32, TF : 9914, TECH FAULT 9914; (B)(6) 2025 14:02:04, VENTILATOR UNIT CONNECTION LOST ALARMS 5024. (B)(6) 2025 14:02:04, VENTILATOR UNIT CONNECTION LOST ALARMS 5024. TO RESOLVE THE ISSUE, THE VU TO IP CABLE AND THE ESM VU WERE REPLACED. AFTER REPLACING THESE COMPONENTS, THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF9914. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249477 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown