BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C2

    MDR report key: 23252929 · Received October 9, 2025

    Report

    Report Number
    3001421318-2025-00850
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    August 23, 2025
    Report Date
    October 23, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K121225
    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) INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REFERENCE: (B)(4). HAMILTON MEDICAL AGS CONCLUSION: BASED ON THE INVESTIGATION REPORT PROVIDED BY HAMILTON MEDICAL TECHNOLOGY (BEIJING) CO., LTD, IT WAS DETERMINED THAT PREVENTIVE MAINTENANCE WAS REQUIRED, BUT NO MALFUNCTION WAS DETECTED ON THE DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE HAMILTON-C2 DEVICE HAS REACHED THE END OF ITS LIFE CYCLE AND HAS BEEN DISCONTINUED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE USE OF THE EQUIPMENT, THERE WAS A FAULT PROMPT, INDICATING THE NEED FOR TURBINE MAINTENANCE. AN ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565031 HAMILTON-C2 HAMILTON-C2 CBK HAMILTON MEDICAL AG 160002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown