BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17487843 · Received August 9, 2023

    Report

    Report Number
    3001421318-2023-02855
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 10, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE VENTILATOR-DEVICE FAILED DURING START-UP. THE GOT ACTIVATED TOGETHER WITH SOME OTHER AUDIBLE AND VISUALLY ALARMS AUTOZERO QAW FAIL, O2 VALVE LEAK ALARM AND THE FLOW SENSOR CALIBRATION ALARM. DURING START-UP SEVERAL ALARMS WERE ACTIVATED WHEREOF FLOW SENSOR CALIBRATION ALARM, THE AUTOZERO QAW FAIL ALARM AND THE O2 VALVE LEAK ALARM. THE ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. PATIENT INVOLVEMENT WAS REPORTED. NEITHER A DELAY OF TREATMENT NOR HARM TO PATIENT, USER OR THIRD PARTY WAS REPORTED TO HAMILTON. INVESTIGATION STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013147 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown