BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-C1

    MDR report key: 24871978 · Received April 14, 2026

    Report

    Report Number
    3001421318-2026-00211
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 14, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. AVAILABLE LOGS WERE REVIEWED AND A ¿BATTERY 1: REPLACEMENT REQUIRED¿ ALARM WAS CONFIRMED. THE FIRST CONFIRMED OCCURRENCE IN THE LOG WAS (B)(6) 2026 17:34:08. HOWEVER, THE COMPLAINT NARRATIVE STATES THE DEVICE ¿SHUT DOWN.¿ WHEN A DEVICE FULLY POWERS OFF WITHOUT USER INTERACTION, A CHARACTERISTIC ¿OFF VENTILATION SOFTWARE¿ LINE IS TYPICALLY ABSENT IN THE LOG SEQUENCE; BASED ON THE PROVIDED LOGS, A COMPLETE POWER-OFF COULD NOT BE CONFIRMED. CLARIFICATION WAS REQUESTED TO RECONCILE WHAT WAS OBSERVED CLINICALLY (FULL POWER LOSS VS DISPLAY/SOFTWARE EXIT VS CONTINUED VENTILATION WITH LIMITED UI FUNCTION) AND TO DETERMINE WHETHER THERE WAS ACTUAL PATIENT IMPACT BEYOND THE NEED FOR MANUAL VENTILATION. LOGS ALSO SHOW REPEATED "BATTERY REPLACEMENT REQUIRED" EVENTS SINCE AT LEAST (B)(6) 2026, WITH THE BATTERY STATE OF HEALTH DECLINING BELOW 20% PRIOR TO THE REPORTED COMPLAINT TIMEFRAME. PER THE SERVICE MANUAL, ¿BATTERY 1: REPLACEMENT REQUIRED¿ IS TRIGGERED WHEN BATTERY SOH DROPS BELOW 20% TO ALERT THAT THE BATTERY MUST BE REPLACED. ON THE DATE REFERENCED IN THE COMPLAINT ((B)(6) 2026), THE LOGS DID NOT SHOW BATTERY ALARMS OR SHUTDOWN EVENTS; INSTEAD, THEY SHOW REPEATED ¿CHECK FLOW SENSOR TUBING,¿ ¿EXTERNAL FLOW SENSOR FAILED,¿ ¿VT LOW,¿ AND ¿DISCONNECTION ON PATIENT SIDE¿ ALARMS, ALONG WITH THE DEVICE AUTOMATICALLY SWITCHING (S)CMV+ TO PCV+. THIS BEHAVIOR IS CONSISTENT WITH EXPECTED DEVICE RESPONSE WHEN FLOW MEASUREMENT ISSUES ARE DETECTED. IT WAS FURTHER NOTED THAT THE LAST RECORDED PRE-OPERATIONAL CHECK WAS ON (B)(6) 2026; PER THE OPERATOR MANUAL, PRE-OP CHECKS ARE REQUIRED BEFORE CONNECTING A NEW PATIENT AND SHOULD BE PERFORMED USING THE BREATHING CIRCUIT INTENDED FOR THE PATIENT. LACK OF A CURRENT PRE-OP CHECK CAN CONTRIBUTE TO DEGRADED PERFORMANCE AND MEANS COMPLIANCE WITH SPECIFICATIONS CANNOT BE ASSURED. INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE DEVICE TRIGGERED THE ALARM ¿BATTERY REPLACEMENT REQUIRED¿ WHILE IT WAS VENTILATING THE PATIENT. THE DEVICE THEN SHUT DOWN, AND THE PATIENT HAD TO BE DISCONNECTED FROM THE VENTILATOR TO RECEIVE MANUAL VENTILATION USING AN AMBU BAG. HARM WAS REPORTED; HOWEVER, THE NARRATIVE ONLY DESCRIBES MANUAL VENTILATION USING AN AMBU BAG, WHICH REPRESENTS A CLINICAL INTERVENTION RATHER THAN PATIENT HARM. FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS ABOUT THE REPORTED EVENT. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932235 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other