BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17815571 · Received September 26, 2023

    Report

    Report Number
    3001421318-2023-10762
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 14, 2022
    Report Date
    September 25, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 15 MONTHS 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 BEING PREPARED FOR TREATMENT. THE ROOT-CAUSE FOR THE EXPIRATORY VALVE ISSUE HAS BEEN A DEFECTIVE EXPIRATORY VALVE. THE PROBLEM WAS CORRECTED BY REPLACING THE DEFECTIVE EXPIRATORY VALVE. THERE WAS NO REPORTED HARM TO PATIENT, USER OR THIRD PARTY.

    Description of Event or Problem · 0

    SELF TEST FAILED TC 231032, 231001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723633 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown