BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17630911 · Received August 28, 2023

    Report

    Report Number
    3001421318-2023-15086
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    March 4, 2022
    Report Date
    August 24, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE TE 233003 AND TE 233004 MALFUNCTION CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED (IFU: "MUST BE SERVICED"). A FULLY FUNCTIONING VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE OF THE VENTILATOR TO ALARM WITH TE 233003 AND TE 233004 WAS DETERMINED TO BE THE CONTAMINATION WITH FLUIDS OF THE PATIENT BREATHING CIRCUIT AND CONNECTED FLOW SENSOR. 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 USED 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

    [1] PNEUMATICS 1- AUTOZERO- QAW 1.2 0.2 L/M; PNEUMATICS 2- NEB.VALVE- QAW: 1.2 1.0 L/M. TESTS FAILED DURING SERVICE SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338234 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown