BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 21262704 · Received January 29, 2025

    Report

    Report Number
    3001421318-2025-00183
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 7, 2025
    Report Date
    November 3, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE UNIT ALARMED WITH FLOW SENSOR CALIBRATION FAILED DURING PREVENTIVE MAINTENANCE. NO PATIENT WAS INVOLVED. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY TO A PATIENT. THE REVIEW OF THE LOGFILES BY THE LOCAL TECHNICIAN CONFIRMED THE ISSUE. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A DEFECTIVE PRESSURE SENSOR BOARD. AFTER REPLACING THE PRESSURE SENSOR BOARD, THE DEVICE WAS RELEASED BACK INTO USE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DETAILED COMPLAINT AND FAILURE DESCRIPTION: "FLOW SENSOR CALIBRATION NEEDED." WHAT CORRECTION HAS BEEN DONE? "ADULT FLOW SENSOR CALIBRATION DID NOT PASS. SO WE HAVE CROSS CHECKED WITH NEW FLOW SENSOR AND CLEAN EXPIRATORY VALVE MEMBRANE BUT PROBLEM REMAINS CONSTANT. WE PERFORMED FLOW TEST IN TSW AND FOUND THAT PROXIMAL FLOW SENSOR QAW VALUES WAS NOT OK AND AUTOZERO TEST ALSO FAILED. SO WE REPLACED THE PRESSURE SENSOR BOARD (P/N -161510) AND DONE ALL TEST AND CALIBRATION SUCCESSFULLY COMPLETED. PLEASE CLOSE THE CER." (2) HEALTH IMPACT: NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792571 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown