BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 21208048 · Received January 22, 2025

    Report

    Report Number
    3001421318-2025-00158
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    January 31, 2024
    Report Date
    January 20, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: THE DEVICE FAILED TO START UP SUCCESSFULLY AND TF 332001 (QAW FLOW SENSOR ERROR) WAS DISPLAYED. TF 332001 INDICATES A TECHNICAL ISSUE WITH THE PROXIMAL FLOW SENSOR QAW. THIS QAW IS MEASURED BY THE PRESSURE SENSOR ASSEMBLY BY MEANS OF 2 PRESSURE SENSORS. MOST LIKELY IT WAS DUE TO A TECHNICAL DEFECT OR DUE TO AN ERROR OF THE QAW SENSOR, WHICH WAS DETECTED BY THE SYSTEM DURING THE INITIALIZATION OF THE COMPONENTS INSTALLED IN THE DEVICE. THE ROOT CAUSE WAS FINALLY IDENTIFIED BY THE SERVICE TECHNICIAN AS A DEFECTIVE PRESSURE SENSOR ASSEMBLY (MSP160870). CORRECTION: THE CORRECTION CONSISTED IN AN EXCHANGE OF THE HAMILTON-C6 PRESSURE SENSOR ASSEMBLY (MSP160870). AFTER REPLACEMENT OF THE PRESSURE SENSOR ASSEMBLY THE VENTILATOR WAS CHECKED SUCCESSFULLY AND RELEASED BACK TO SERVICE.

    Description of Event or Problem · 0

    THE UNIT SHOWS AN ALARM "SELF-TEST FAILED" AND OCCURS TF 332001. AFTER REPLACING THE PRESSURE SENSOR ASSEMBLY, THE UNIT RETURNS TO NORMAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943665 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown