BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON C3

    MDR report key: 10507517 · Received September 8, 2020

    Report

    Report Number
    MW5096487
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 4, 2020
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE HAMILTON C3 VENTILATOR WHICH WAS PROVIDING VENTILATION TO THE PATIENT APPEARED TO HAVE SHUT DOWN OR ENTERED A STATE OF UNRESPONSIVENESS WITHOUT AUDIBLE ALARMING. THE PATIENT MONITORING SYSTEM ALERTED THAT THE SPO2 OF THE PATIENT WAS DROPPING. WHEN THE NURSING STAFF RESPONDED, THEY FOUND THE VENTILATOR IN A STATE WHERE THE VISUAL INDICATOR ON THE TOP OF THE DEVICE AND AROUND THE SILENCE BUTTON HAD BEEN TRIGGERED TO ILLUMINATE RED AND THE SCREEN WAS BLACK/BLANK. THE VENTILATOR WAS REMOVED AND ALTERNATIVE MEANS OF VENTILATION HAD TO BE ADMINISTERED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964831 HAMILTON C3 VENTILATOR, CONTINUOUS, FACILITY USE CBK HAMILTON MEDICAL AG C3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention