BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 20210873 · Received September 13, 2024

    Report

    Report Number
    3001421318-2024-02197
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 15, 2024
    Report Date
    November 5, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800754
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG EVENT REFERENCE NUMBER: CER (B)(4). THE INTERNAL PRODUCT INVESTIGATION IS STILL ONGOING. AS SOON AS THE RESULTS ARE AVAILABLE, THE MANUFACTURER WILL SUBMIT AN UPDATE OF THIS REPORT UNSOLICITED.

    Description of Event or Problem · 0

    THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: CUSTOMER COMPLAINED OF REPLACING EXPIRATORY VALVE ASSM AND CHECKVALVE MORE THAN NORMAL EVERY 3 MONTHS TYPICAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129728 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161005 07630002800754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown