BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 23433906 · Received October 31, 2025

    Report

    Report Number
    3001421318-2025-00887
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    September 19, 2025
    Report Date
    April 27, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: IT WAS REPORTED THAT THE DEVICE SWITCHED MODES ITSELF. THE ISSUE WAS IDENTIFIED DURING VENTILATION, BUT NO MEDICAL INTERVENTION OR HARM TO THE PATIENT, USER, OR ANY THIRD PARTY WAS REPORTED. REVIEW OF THE DEVICE EVENT LOGS CONFIRMED MULTIPLE TRANSITIONS BETWEEN (S)CMV+ AND PCV+ MODES ASSOCIATED WITH ¿EXTERNAL FLOW SENSOR FAILED¿ AND ¿CHECK FLOW SENSOR TUBING¿ ALARMS. THIS BEHAVIOUR IS CONSISTENT WITH THE VENTILATOR¿S DESIGNED RESPONSE, WHERE DETECTION OF A FLOW SENSOR ISSUE FOR MORE THAN THREE BREATH CYCLES INITIATES SENSOR FAILURE MODE WITH AUTOMATIC FALLBACK TO PCV+ VENTILATION, FOLLOWED BY RETURN TO THE PREVIOUS MODE ONCE THE CONDITION RESOLVES. NO EVIDENCE OF DEVICE MALFUNCTION WAS IDENTIFIED, AS THIS MODE SWITCHING REPRESENTS EXPECTED SAFETY FUNCTIONALITY TO ENSURE CONTINUED VENTILATION. POTENTIAL CONTRIBUTING FACTORS INCLUDE TRANSIENT OR INTERMITTENT ISSUES WITHIN THE FLOW SENSOR SYSTEM, SUCH AS TUBING OCCLUSION, MISCONNECTION, CALIBRATION DEVIATION, PATIENT-RELATED FACTORS (E.G., COUGHING OR BREATHING EFFORT), OR DISTURBANCES IN PRESSURE/FLOW MEASUREMENTS. THE LOCAL SERVICE ENGINEER PERFORMED A FULL SERVICE SOFTWARE CHECK, FUNCTIONAL VERIFICATION, AND ELECTRICAL SAFETY TESTING WITH NO FAULTS DETECTED, AND TEST SIMULATIONS DID NOT REPRODUCE THE ISSUE. THE DEVICE WAS UPDATED TO THE LATEST SOFTWARE VERSION (3.1.1), AND MINOR PHYSICAL DAMAGE (COVERS) WAS CORRECTED WITHOUT IMPACT ON DEVICE PERFORMANCE. NO PATIENT OR USER HARM WAS REPORTED. THE COMPLAINT IS CONCLUDED AS EXPECTED DEVICE BEHAVIOUR WITH NO CONFIRMED DEVICE DEFICIENCY, AND NO FURTHER CORRECTIVE ACTION IS REQUIRED BEYOND ROUTINE MONITORING AND PROPER HANDLING OF FLOW SENSOR COMPONENTS. THIS CASE IS CONSIDERED AS CLOSED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (B)(4).

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "HOSPITAL STAFF SAYS THAT DURING VENTILATION THE DEVICE SWITCHED MODES. FROM MODE ASSIST CONTROL TO PC? ALSO HAD O2 SENSOR ALARMS. NOT A LOT OF INFORMATION WAS GIVEN ABOUT THE EVENT!" NO HEALTH CONSEQUENCES OR IMPACT. NO INTERVENTION NECESSARY. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907216 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown