BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17805765 · Received September 25, 2023

    Report

    Report Number
    3001421318-2023-11513
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 25, 2022
    Report Date
    September 22, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 NOT IN USE. THE ROOT CAUSE CAN'T BE DETERMINED PRECISELY BUT IT IS LINKED TO THE DEFECTIVE BREATHING CIRCUIT SET AS PER THE CORRECTION. IN CONSEQUENCE BREATHING SET WAS REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    H900 BREATHING CIRCUIT SET PN 260185 WITH Y PIECE PN 279965 NOT TIGHT (LEAKAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294950 HAMILTON MEDICAL AG HAMILTON-H900 CBK HAMILTON MEDICAL AG HAMILTON-H900 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown