BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 24001679 · Received January 8, 2026

    Report

    Report Number
    3001421318-2026-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    August 7, 2025
    Report Date
    January 8, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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. THE DEVICE ALARMED WITH "PANEL CONNECTION LOST" ON THE DAY OF THE EVENT. IT IS IMPORTANT TO EMPHASIZE THAT NO PATIENT WAS INVOLVED AT THE TIME THE ALARM OCCURRED. PLEASE SEE BELOW EXTRACT FROM THE LOGFILES. (B)(6) 2000 00:14:58 EXPIRATORY VALVE CALIBRATION NEEDED ALARMS 3006. (B)(6) 2000 00:14:58 O2 SENSOR CALIBRATION NEEDED ALARMS 3003. (B)(6) 2025 19:28:20 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 19:28:10 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 19:02:01 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 19:01:51 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 18:23:27 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 18:23:17 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 11:46:56 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 11:46:46 PANEL CONNECTION LOST ALARMS 4010. THE "PANEL CONNECTION LOST" ALARM INDICATES THAT COMMUNICATION BETWEEN THE INTERACTION PANEL AND THE VENTILATION UNIT IS INTERRUPTED. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE EMBEDDED SYSTEM MODULE OF THE VENTILATION UNIT (VU ESM). AFTER THE COMPONENT WAS REPLACED, THE DEVICE SUCCESSFULLY PASSED ALL FUNCTIONAL TESTS AND HAS BEEN OPERATING AS INTENDED, WITHOUT ANY FURTHER ISSUES. AT THE TIME OF THE EVENT, THE DEVICE HAD AN AGE OF 17 YEARS.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: AFTER THE DEVICE WAS SWITCHED ON, IT ALARMED WITH "PANEL CONNECTION LOST". NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66286 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown