BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 23756021 · Received December 9, 2025

    Report

    Report Number
    3001421318-2025-00956
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    December 2, 2025
    Report Date
    April 13, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    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: IT WAS REPORTED THAT THE VENTILATOR DISPLAYED REPEATED ¿OXYGEN SUPPLY FAILED¿ ALARMS DURING TESTING ON A TEST LUNG. LOGFILE ANALYSIS SHOWED MULTIPLE OXYGEN SUPPLY FAILURE EVENTS ON 02 DEC 2025 UNDER VARYING OXYGEN SETTINGS. THE EVENTS WERE CONSISTENT WITH A MALFUNCTION OF THE O2 MIXER ASSEMBLY, WHICH WAS REPLACED. AFTER REPLACEMENT AND COMPLETION OF ALL REQUIRED TESTS AND CALIBRATIONS, THE VENTILATOR PASSED ALL FUNCTIONAL TESTS AND OPERATED NORMALLY. THE VENTILATOR WAS RETURNED TO SERVICE. NO PATIENT WAS INVOLVED, NO HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE IS NO INDICATION THAT THE EVENT RESULTED IN DEATH, INJURY, OR ANY DETERIORATION IN THE HEALTH OF A PATIENT, USER, OR THIRD PARTY. CASE IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: OXYGEN SUPPLY FAILED DURING TESTING ON TEST LUNG OF VENTILATOR. 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
    429734 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1