BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 4254856 · Received November 10, 2014

    Report

    Report Number
    3004526033-2014-00019
    Event Type
    Death
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 17, 2014
    Manufacturer
    VIDACARE
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO: THIS REPORT WAS DETERMINED TO BE A DEATH EVEN THOUGH THE EMS PERSONNEL INFORMED US THE DEVICE WAS NOT A CONTRIBUTING FACTOR TO THE DEMISE OF THE PT. EMS PERSONNEL DO NOT MEET THE GUIDANCE OF OUR PROCEDURE. A PHYSICIAN COULD NOT BE CONTACTED TO VERIFY STATEMENT BY EMS PERSONNEL.

    Description of Event or Problem · 1

    SEE MDR# 3000526033-2014-00018 FOR THE FIRST INSERTION FOR THE SAME PT WITH THE EZ-IO. IT WAS REPORTED A SECOND LINE WAS BEING PLACED INTO A MALE PT IN A CODE SITUATION. THEY ATTEMPTED THE PROCEDURE INTO THE PT'S RIGHT TIBIA. AGAIN, THEY HAD POWER TO THE EZ-IO DRIVER AND AS SOON AS THE NEEDLE PENETRATED THE PT'S SKIN THEY HAD NO POWER TO THE DRIVE. THE TECH HAND SCREWED THE NEEDLE INTO THE PT. IT WAS NOTED THAT THE NORMAL PRESSURE WAS APPLIED DURING BOTH INSERTIONS. THE PT EXPIRED, HOWEVER, IT WAS NOTED THE ISSUES WITH THE DRIVER WERE NOT A CONTRIBUTING FACTOR TO THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722479 EZ-IO POWER DRIVER EZ-IO INTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death