BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17651460 · Received August 30, 2023

    Report

    Report Number
    3001421318-2023-12061
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 2, 2022
    Report Date
    August 29, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS PREPARED FOR TREATMENT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE PRESSURE SENSOR ASSEMBLY (PSA). IN CONSEQUENCE THE PRESSURE SENSOR ASSEMBLY HAS BEEN REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    VOLUME- AND FLOW-CURVES ARE UNSTABLE AND DOES NOT GIVE THE RIGHT WAVES ON THE TEST LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287609 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown