BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17650005 · Received August 30, 2023

    Report

    Report Number
    3001421318-2023-14114
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    May 12, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 BEING USED. THE ROOT CAUSE WAS DETERMINED TO BE MISALIGNED BLOWER MODULE, WHICH WAS REPLACED AND THE SYSTEM THEN BROUGHT BACK TO OPERATION AS INTENDED. 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 SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    SELF TEST FAILED OCCURRED WITH TECHNICAL EVENTS, TE 232029, TE 232008 AND TE 232035 DURING STARTUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398424 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown