BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 21629439 · Received March 18, 2025

    Report

    Report Number
    3001421318-2025-00435
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    November 14, 2024
    Report Date
    March 20, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: THE CASE IS NOT REPORTABLE BECAUSE THE ISSUE WAS CAUSED BY USER ERROR, NOT A DEVICE MALFUNCTION. THE INCORRECT ADAPTER KIT WAS USED, WHICH LED TO DEVICE OSCILLATION DURING NEONATAL TREATMENT. SINCE THE DEVICE ITSELF FUNCTIONED AS INTENDED WHEN USED CORRECTLY, THERE IS NO FAILURE THAT COULD POSE A POTENTIAL RISK UNDER NORMAL USE CONDITIONS. THE ISSUE WAS RESOLVED BY INSTALLING NEONATAL CIRCUIT ADAPTER, PN 160595.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "WHEN THE DEVISES ARE WORKING IN NIV, NCPAP OR CMV PRESENT AN AUTO TRIGGER WITH SENSIBILITY CONFIGURED IN FLOW TRIGGER = 0.5 L/M OR MORE. THIS WAS REPRODUCIBLE WITH TESTS BAG. ADDITIONALLY, THE DEVICES HAVE A SOUND OF VIBRATION IN THE EXPIRATORY VALVE. WE THINK THAT THIS NOISE IS FROM THE INSPIRATORY VALVE BUT IS REFLECTED IN THE EXPIRATORY VALVE. IN CONCORDANCE, IN A PREVENTIVE WAY, WE THINK THAT COULD BE NECESSARY THE NEONATAL CIRCUIT ADAPTER FOR THIS DEVICE." HEALTH IMPACT: NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "WHEN THE DEVISES ARE WORKING IN NIV, NCPAP OR CMV PRESENT AN AUTO TRIGGER WITH SENSIBILITY CONFIGURED IN FLOW TRIGGER = 0.5 L/M OR MORE. THIS WAS REPRODUCIBLE WITH TESTS BAG. ADDITIONALLY, THE DEVICES HAVE A SOUND OF VIBRATION IN THE EXPIRATORY VALVE. WE THINK THAT THIS NOISE IS FROM THE INSPIRATORY VALVE BUT IS REFLECTED IN THE EXPIRATORY VALVE. IN CONCORDANCE, IN A PREVENTIVE WAY, WE THINK THAT COULD BE NECESSARY THE NEONATAL CIRCUIT ADAPTER FOR THIS DEVICE." HEALTH IMPACT: NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823218 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown