BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 4264389 · Received November 7, 2014

    Report

    Report Number
    3004526033-2014-00012
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    VIDACARE
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE EZ-IO WAS BEING USED ON A PT WHO WAS CODING. THE GREEN INDICATOR LIGHT WAS LIT ON THE POWER DRIVER. THE EMS TECH ATTEMPTED TO USE THE POWER DRIVER ON THE PT'S LEG. THEY TESTED THE DRIVER AND HAD POWER. AT WHICH TIME, THEY PROCEEDED WITH THE NEEDLE INSERTION. ONCE THEY HIT BONE POWER WAS IMMEDIATELY LOST. THEY WERE UNABLE TO INSERT AN IV INTO THE PT. THE PT LATER EXPIRED. THE EMS STATED THE PT WAS IN A CODE SITUATION PRIOR TO THE USE OF THE EZ-IO. THE EMS STATED THIS ISSUE DID NOT CONTRIBUTE TO THE PT'S OUTCOME. IT WAS NOTED THE CLINICIAN TESTED THE UNIT LATER AND IT WORKED FINE ON THE DEMO LEG. POWER WAS NOT LOST. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720667 EZ-IO POWER DRIVER EZ-IO IINTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death