BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON G5 VENTILATOR

    MDR report key: 11463209 · Received March 10, 2021

    Report

    Report Number
    MW5099948
    Event Type
    Injury
    Date Received
    March 10, 2021
    Report Date
    March 9, 2021
    Manufacturer
    MED ONE EQUIPMENT SERVICES, LLC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICU RN HEARD VENT ALARMING, RED ALARM FLASHING, WENT IN TO CHECK ON PATIENT. ETT INTACT AND CONNECTED TO TUBING. TRACED TUBING BACK TO THE MACHINE AND WAS NOTED THAT THE INHALATION PORT WAS DISCONNECTED. IMMEDIATELY REPLACED. PATIENT WENT BRADY THEN LOST PULSE, IMMEDIATELY STARTED CPR WHILE CODE BLUE CALLED, PEA, EPI, AMIODARONE, DEFIB X 2 AND ROSC OBTAINED. VENTILATOR TUBING BECAME DISCONNECTED FROM THE VENTILATOR, UNKNOWN WHY THE TUBING BECAME DISCONNECTED FROM THE VENTILATOR. HAMILTON G5 VENTILATOR. THERAPY START DATE (B)(6) 2021, THERAPY END DATE (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346694 HAMILTON G5 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK MED ONE EQUIPMENT SERVICES, LLC EIN 1238831

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening