BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 21189916 · Received January 20, 2025

    Report

    Report Number
    3001421318-2025-00145
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    December 20, 2024
    Report Date
    November 21, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813426
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS COMPLAINT HAS BEEN RECEIVED AS: "HOSPITAL STAFF SAYS DEVICE ALARMED FOR FLOW SENSOR, FLOW SENSOR WAS CHANGED BUT ALARM CONTINUED, SAYS THE DEVICE ALSO CHANGED MODES FROM APV TO PRESSURE CONTROL WITHOUT STAFF INPUT." THIS RECORD CONTAINS INFORMATION OF PATIENT INVOLVEMENT. THE PROBLEM WAS IDENTIFIED DURING VENTILATION. THE PATIENT WAS BAGGED AS A RESULT OF THE EVENT. NEITHER HARM TO PATIENT, USER OR THIRD PARTY NOR A TREATMENT DELAY WAS REPORTED. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. THE LAST PREVENTIVE MAINTENANCE HAS BEEN PERFORMED ON 03.12.2024 AND ALL TEST PASSED. CHECK FLOW SENSOR, EXTERNAL FLOW SENSOR FAILED AND LOW MINUTE VOLUME ALARMED SEVERAL TIMES ON (B)(6) 2024 (DATE OF EVENT) AND BEFORE THIS DATE. REGARDING THE OTHER REPORTED EVENT THE DEVICE ALSO CHANGED MODES FROM APV TO PRESSURE CONTROL WITHOUT STAFF INPUT.: THE DEVICE SWITCHED TO SENSOR FAILURE MODE AND AS A RESULT FROM SIMV+ MODE TO PCV+ MODE. ACCORDING TO THE AVAILABLE INFORMATION THE FAILURE WAS NOT REPRODUCIBLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING VENTILATION, "HOSPITAL STAFF SAYS DEVICE ALARMED FOR FLOW SENSOR, FLOW SENSOR WAS CHANGED BUT ALARM CONTINUED". THE DEVICE ALSO CHANGED MODES FROM APV TO PRESSURE CONTROL WITHOUT STAFF INPUT. THE PATIENT WAS BAGGED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489312 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 1610010 07630002813426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown