BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 20209882 · Received September 13, 2024

    Report

    Report Number
    3001421318-2024-02199
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 13, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DEVICE ALARMED LOW-PRIORITY AND READ "PREVENTIVE MAINTENANCE REQUIRED", ALARM SILENCED AND ALERT WENT AWAY. ABOUT AN HOUR LATER DEVICE STOPPED VENTILATING PATIENT. ALARMED "PATIENT DISCONNECT". CONNECTIONS CHECKED AND EVERYTHING SECURE, HME EXCHANGED, PATIENT BAGGED VIA MVU AND VENTILATING FINE. PATIENT PLACED BACK ON T1 VENTILATOR AND WORKING WELL FOR AROUND 1 MINUTE BEFORE IT STOPPED VENTILATING AGAIN.". THERE WAS A REPEAT OF A RED ALARM "LOW MINUTE VOLUME" THAT HAD HAPPENED A FEW TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112684 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown