BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17753420 · Received September 15, 2023

    Report

    Report Number
    3001421318-2023-10957
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 11, 2022
    Report Date
    September 12, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTIONS "TIGHTNESS TEST FAILED" AND "FLOW SENSOR TEST FAILED" CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED. A FULLY FUNCTIONING VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE WAS DETERMINED TO BE AN INTERNAL LEAKAGE, AMBIENT VALVE AND OXYGEN SENSOR WERE NOT PROPERLY TIGHTENED. ALSO, THE O2 CELL WAS CLOSE TO EXPIRATION WHEN THE EVENT OCCURRED. THE CORRECTION IN THIS CASE WAS THE REPLACEMENT OF THE AMBIENT VALVE AND O2 CELL. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT, WHILE THE MEDICAL DEVICE WAS PREPARED FOR TREATMENT. THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT LIKE THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE REPORT FROM HOSPITAL SAY DURING THE USE OF THE VENTILATOR FOR THE PATIENT, THE MACHINE MADE A SHORT ABNORMAL SOUND. HAMILTON-C3 MADE IN NOV. 16, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302997 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown