BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23412387 · Received October 29, 2025

    Report

    Report Number
    3001421318-2025-00882
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 29, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. ALL IMPORTANT ACTIONS SUCH AS OPERATOR SETTINGS, ACTIONS AND ALARMS, ETC. ARE DOCUMENTED IN THE LOGFILES. BASED ON THE LOGFILE ANALYSIS, THE CUSTOMER¿S REPORTED ISSUE HAS BEEN CONFIRMED. THE DEVICE GENERATED AN ALARM TF 5505, 5502. ON (B)(6) 2025, 15:31:07 TF : 5505 TECH FAULT 5505, ON (B)(6) 2025, 15:31:06 ETS 25 % SETTING 319, ON (B)(6) 2025, 15:31:04 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6) 2025, 15:31:04 TF : 5502 TECH FAULT 5502, ON (B)(6) 2025, 15:31:03 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6) 2025, 15:31:02 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6) 2025, 15:31:02 TF : 5505 TECH FAULT 5505, ON (B)(6) 2025,15:31:02 SCREEN LOCK ON SPECIAL 518, ON (B)(6) 2025, 15:31:01 NEBULIZER OFF SPECIAL 501, ON (B)(6) 2025, 15:31:01 NEBULIZER ON SPECIAL 500, ON (B)(6) 2025, 15:31:00 O2 ENRICHMENT SPECIAL 512. TO ADDRESS THE ISSUE A REPLACEMENT INSPIRATORY VALVE WAS SENT TO THE END CUSTOMER. FOLLOWING THE REPLACEMENT OF THE INSPIRATORY VALVE, THE DEVICE WORKED AS INTENDED. HAMILTON MEDICAL CONSIDERS THIS CASE AS CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF 5505, 5502. THE PATIENT WAS SWITCHED TO ALTERNATIVE VENTILATOR NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210353 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown