BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 23836284 · Received December 18, 2025

    Report

    Report Number
    3001421318-2025-00978
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    December 2, 2025
    Report Date
    May 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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REFERENCE: (B)(4). HAMILTON MEDICAL AGS CONCLUSION: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REFERENCE: (B)(4); HAMILTON MEDICAL AGS FOLLOW UP: IT WAS REPORTED THAT THE ACTIVE HUMIDIFICATION WAS FOUND SWITCHED OFF AND THAT THE BREATHING CIRCUIT FILLED WITH WATER AFTER REACTIVATION.THE LOGFILE ANALYSIS SHOWED NO TECHNICAL FAULTS/ TECHNICAL EVENTS, NO AMBIENT STATED CONDITIONS AND NO DEVICE-RELATED DEVIATIONS. THE FIELD ENGINEER IN BERN DID NOT FOUND DEVIATIONS ON THE SERVICE SOFTWARE TEST. THE MANUFACTURER INTENDS TO CONTINUE THE INVESTIGATION BY OBTAINING ADDITIONAL INFORMATION. THE MANUFACTURER SECURED AND REVIEWED THE AVAILABLE LOG FILES. AS SOON AS NEW INFORMATION BECOMES AVAILABLE, WE WILL PROVIDE AN UPDATE; OTHERWISE, WE WILL REPORT BACK NO LATER THAN THE AGREED FOLLOW-UP DATE.

    Description of Event or Problem · 0

    HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): THE USER OBSERVED THAT THE ACTIVE HUMIDIFICATION ON THE VENTILATOR WAS SWITCHED OFF AND, AFTER REACTIVATION, THE BREATHING CIRCUIT FILLED WITH WATER, CAUSING LEAKAGE WHEN THE EXPIRATORY FILTER WAS DISCONNECTED. THE PATIENT WAS BRIEFLY DISCONNECTED, VENTILATED MANUALLY, AND THE VENTILATOR WAS REPLACED; THE PATIENT REMAINED STABLE. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113477 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1