BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 20062822 · Received August 26, 2024

    Report

    Report Number
    3001421318-2024-02065
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 20, 2024
    Report Date
    January 27, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - DEVICE EVALUATION: ROOT CAUSE: THE DEVICE ALARMED WITH TE 233004 (AUTOZERO QAW FAIL) WITH NO PATIENT INVOLVEMENT. THERE WAS NO PRIOR MALFUNCTION REPORTED WITH PATIENT INVOLVEMENT. A "TE", I.E., A TECHNICAL EVENT DOES NOT END UP WITH A SHUTDOWN OF THE DEVICE. HOWEVER, WHEN GOING THROUGH THE LOG FILES, IT WAS FOUND THAT, AT SOME POINT AFTER THE TE 233004 OCCURRED, THE DEVICE WAS STARTED UP AND TF 332001 (QAW FLOW SENSOR ERROR) OCCURRED. THIS PUT THE DEVICE INTO THE SAFETY VENTILATION STATE. THERE WAS NO PATIENT INVOLVEMENT. HOWEVER, IF THIS OCCURRED DURING VENTILATION OF A PATIENT, THE DEVICE WOULD STILL VENTILATE THE PATIENT, BUT BASED ON A WEIGHT-BASED VENTILATION (NOT THE ENTERED VALUES) AND AN ALTERNATIVE VENTILATION DEVICE WOULD HAVE TO BE ORGANIZED AT SOME POINT. THEREFORE, THE CASE WAS CONSERVATIVELY REPORTED. THE DEVICE ALARMED WITH TE 233004 (AUTOZERO QAW FAIL) AND LATER ON FAILED TO START UP SUCCESSFULLY AND TF 332001 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 CORRECTION CONSISTED OF AN EXCHANGE OF THE HAMILTON-C6 PRESSURE SENSOR ASSEMBLY (B)(6). AFTER REPLACEMENT OF THE PRESSURE SENSOR ASSEMBLY, THE VENTILATOR WAS CHECKED SUCCESSFULLY AND RELEASED BACK TO SERVICE. UPDATED FIELDS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TE 233004 AND "SELFTEST FAILED" DURING START UP.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TE 233004 AND "SELFTEST FAILED" DURING START UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160081 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown