BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 24647096 · Received March 20, 2026

    Report

    Report Number
    3001421318-2026-00151
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 20, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. THE DEVICE WAS OPERATING IN HIFLOW O2 MODE AT 11:37:19. AT 14:28:25, IT WAS PLACED INTO STANDBY. AT 14:29:08, THE DEVICE WAS POWERED ON INTO THE VENTILATION SOFTWARE. SUBSEQUENTLY, ERROR CODE TF341009 (PVENTPRESSURESENSORDEFECT) WAS RECORDED AT 14:29:20, FOLLOWED BY TE231036 AT 14:29:24. AT 14:29:30, A SELF-TEST FAILURE WAS LOGGED. AT 14:32:54, OFF VENTILATION SOFTWARE IS LOGGED. PLEASE SEE BELOW AN EXTRACT FROM THE LOGFILES: 38/2026-02-23 14:32:54/POWER /OFF VENTILATION SOFTWARE. 41/2026-02-23 14:29:30/!!! /SELF TEST FAILED. 54/2026-02-23 14:29:24/!!! /TECHNICAL EVENT:231036. 58/2026-02-23 14:29:20/TF /341009 67/2026-02-23 14:29:08/POWER /AC 68/2026-02-23 14:29:08/POWER /ON VENTILATION SOFTWARE. 69/2026-02-23 14:28:28/POWER /OFF VENTILATION SOFTWARE. 70/2026-02-23 14:28:26/SPECIAL /HUMIDIFIER STANDBY ON. 71/2026-02-23 14:28:25/MODE /HIFLOWO2 => STANDBY. 99/2026-02-23 11:37:19/MODE /STANDBY => HIFLOWO2. THERE IS NO EVIDENCE OF AN ABNORMAL OR SPONTANEOUS RESTART IN THE LOGS. INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE HAMILTON VENTILATOR WAS IN USE FOR A TRACHEOSTOMY PATIENT ON HIGH FLOW SETTING. A TRANSITION BACK TO SPONT MODE WAS PLANNED. THE VENTILATOR WAS PLACED IN STANDBY MODE TO ADJUST THE SETTINGS; HOWEVER, ALL OPTIONS "REMAINED FOGGED OUT AS IF UNAVAILABLE." AN ATTEMPT WAS MADE TO SELECT THE SPONT MODE TO SEE IF IT WOULD WORK. SUBSEQUENTLY, THE DISPLAY WENT BLANK AND SHOWED A LOADING BAR, AS IF MACHINE WAS RESTARTING. THE PATIENT WAS MANUALLY VENTILATED WHILE A REPLACEMENT VENTILATOR WAS PREPARED. SHORTLY THEREAFTER, THE INITIAL VENTILATOR DISPLAY REACTIVATED AND GENERATED A ¿TECHNICAL FAULT¿ ALARM. THE PATIENT WAS MOVED TO THE NEW VENTILATOR AND THE AFFECTED DEVICE WAS REMOVED FROM USE. NO HARM TO THE PATIENT WAS REPORTED. THE MEDICAL TEAM AND NIC WERE PRESENT THROUGHOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714561 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown