BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 24050609 · Received January 13, 2026

    Report

    Report Number
    3001421318-2026-00016
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 27, 2025
    Report Date
    January 13, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    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) 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. 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. PLEASE SEE BELOW EXTRACT FROM THE LOGFILES. (B)(6) 2025, 08:14:58 VOLUME LIMITATION ALARMS 4085, (B)(6) 2025, 08:14:52 TF : 2454 TECH FAULT 2454, (B)(6)2025, 08:14:26 TF : 9950 TECH FAULT 9950, (B)(6)2025, 08:14:24 TF : 9958 TECH FAULT 9958, (B)(6)2025, 08:14:24 TF : 2103 TECH FAULT 2103, (B)(6)2025, 08:14:24 TF : 1950 TECH FAULT 1950, (B)(6)2025, 08:14:24 TF : 2103 TECH FAULT 2103, (B)(6)2025, 08:14:24 TF : 1950 TECH FAULT 1950, (B)(6)2025, 08:14:24 AUDIO PAUSED OFF SPECIAL 517, (B)(6)2025,08:14:24 TF : 9957 TECH FAULT 9957, (B)(6)2025, 08:14:18 TF : 2450 TECH FAULT 2450, (B)(6)2025, 08:14:18 TF : 2450 TECH FAULT 2450, (B)(6)2025, 08:13:38 AUDIO PAUSED ON SPECIAL 516, (B)(6)2025, 08:13:36 HIGH TIDAL VOLUME ALARMS 4006, (B)(6)2025, 08:13:23 %TI 26 % SETTING 309, (B)(6)2025, 08:13:14 RATE 16 B/MIN SETTING 314, (B)(6)2025, 08:12:19 OXYGEN 40 % SETTING 302. A REPLACEMENT IP ESM BOARD WAS PROVIDED TO THE USER TO ADDRESS THE REPORTED ISSUE. ACCORDING TO THE INFORMATION RECEIVED, THIS RESOLVED THE ISSUE. HAMILTON MEDICAL CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE VENTILATION OF A PATIENT, THE DEVICE ALARMED WITH TF: 9950, TF: 9957, TF: 9958 AND SCREEN FROZE. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115701 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown