BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-C2

    MDR report key: 8727488 · Received June 24, 2019

    Report

    Report Number
    2937708-2019-00002
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 21, 2019
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    PATIENT SETTING WAS NIV-ST THEN INTUBATED. TWO BATTERIES INDICATED RED AND PLUG INDICATOR HAD RED X. USER UNPLUGGED VENTILATOR THEN PLUGGED THE VENTILATOR BACK INTO WALL AC, THEN RECEIVED A BATTERY COMMUNICATION ERROR. SCREEN FROZE AND THE VENT STOPPED AND FROZE ON A SELF-TEST SCREEN. BAGGED PATIENT AND SWITCHED TO A HAMILTON-C1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522764 HAMILTON-C2 C2 CBK HAMILTON MEDICAL AG C2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention