BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 4301219 · Received December 2, 2014

    Report

    Report Number
    3004526033-2014-00029
    Event Type
    Death
    Date Received
    December 2, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 23, 2014
    Manufacturer
    VIDACARE
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PARAMEDICS FAILED TWICE WHEN TRYING TO USE THE EZ-IO DRIVER ON THE PATIENT AND WERE UNABLE TO GIVE THE PATIENT AN INTRAOSSEOUS INFUSION. THE POWER WORKED FOR A FEW SECONDS AND THEN STOPPED. THE PATIENT WAS ONLY INFUSED WHEN THE AMBULANCE ARRIVED 10 MINUTES LATER. THE PATIENT PASSED AWAY. IT WAS NOTED THE DRIVE WAS PUT INTO SERVICE ON (B)(6) 2013. THERE HAVE BEEN ABOUT 15 INSERTIONS WITH THE DEVICE SINCE THAT TIME AND WAS LAST USED ON (B)(6) 2014 WITH NO PROBLEMS. THEY HAVE NOT TESTED THE DEVICE EVERY MORNING TO SEE IF IT WORKS. THE DRIVER WAS STORED IN THE BAG WITH THE TRIGGER GUARD ON IN THE THERMO-WELDED PLASTIC CASE. NO RED LIGHT INDICTING NO POWER AND NO SIGN OF THE ENGINE SLOWING DOWN PRIOR TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777067 EZ-IO POWER DRIVER EZ-IO INTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death