BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16945538 · Received May 17, 2023

    Report

    Report Number
    3001421318-2023-01859
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    May 16, 2023
    Report Date
    August 28, 2023
    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`S CONCLUSION FOR THIS EVENT: THE ROOT CAUSE ANALYZED FOR THIS EVENT IS CONFIRMED TO BE THE MISUSE OF THE DEVICE. THE CONDENSATION WATER FROM HAMILTON-H900, RUNS INTO THE PRESSURE SENSOR ASSEMBLY. BECAUSE THE CIRCUIT (BREATHING CIRCUIT) WAS NOT REMOVED FROM THE HAMILTON-C6 FOR THE CONSEQUENCES ESTABLISHED THE DEVICE FAILS TO MEET THE SPECIFICATION DURING THE CALIBRATION. THE FAILURE OF THE SELF-TEST OF SERVICE SOFTWARE DESCRIBES IN CHAPTER 7.8.1.1.2 PRESSURE OF SERVICE MANUAL HAMILTON-C6, CONFIRMED THE FAILURE OF THE PART PRESSURE SENSOR ASSEMBLY. THE OPERATOR MANUAL OF HAMILTON-C6 DESCRIBES HOW TO DISPOSE OF THE BREATHING CIRCUIT AFTER THE DEVICE IS SWITCHED OFF TO AVOID CONTAMINATION. THE ROOT CAUSE IS RELATED TO A USE ERROR. THE VENTILATOR WAS TAKEN OUT OF SERVICE AND THE RE-CALIBRATION ROUTINE WAS EXECUTED. PRESSURE SENSOR ASSEMBLY MSP 160870 WAS REPLACED AND CONFIRMED. ALL TECHNICAL SERVICE SOFTWARE WAS PERFORMED AND DOCUMENTED WITH NO DEVIATION. THE PART WAS NOT RETURNED FOR AN INTERNAL INVESTIGATION. NO RGA WAS REQUESTED FOR THE PRESSURE SENSOR BOARD MSP 160870. THE VENTILATOR WAS BROUGHT BACK INTO SERVICE.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG`S CONCLUSION FOR THIS EVENT: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: VENTILATOR USED WITH HEATED/HUMIDIFIED H900 CIRCUIT. VENTILATOR WAS PUT IN TO STANDBY. BREATHING CIRCUIT Y-PIECE AND FLOWSENSOR WHERE POSITIONED IN A WAY, THAT CONDENSED WATER WAS RUNNING THROUGH THE FLOWSENSOR PRESSURE LINES TOWARDS THE VENTILATOR. HYPOTHESIS: WATER RAN INTO THE PRESSURE SENSOR ASSEMBLY. BINARY VALVE COMP TEST IN SERVICE SOFTWARE: PROX AUTOZERO VALVE OPERATION AND AUTOZERO FAILED REPEATED A COUPLE OF TIMES, NOT SUCCESSFUL..

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: VENTILATOR USED WITH HEATED/HUMIDIFIED H900 CIRCUIT. VENTILATOR WAS PUT IN TO STANDBY. BREATHING CIRCUIT Y-PIECE AND FLOWSENSOR WHERE POSITONED IN A WAY, THAT CONDENSED WATER WAS RUNNING THROUGH THE FLOWSENSOR PRESSURE LINES TOWARDS THE VENTILATOR. HYPOTHESIS: WATER RAN INTO THE PRESSURE SENSOR ASSEMBLY. BINARY VALVE COMP TEST IN SERVICE SOFTWARE: PROX AUTOZERO VALVE OPERATION AND AUTOZERO FAILED REPEATED A COUPLE OF TIMES, NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543080 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown