BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 4683930 · Received April 10, 2015

    Report

    Report Number
    3004526033-2015-00026
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 28, 2015
    Report Date
    April 1, 2015
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IO WAS BEING PLACED INTO A PT'S TIBIA. ACCESS WAS BEING OBTAINED IN AMBULANCE GROUND UNIT PRIOR TO AIR LIFT TO HOSPITAL. THE CLINICIAN INSERTED THE IO THROUGH THE PT'S SKIN, HOWEVER, WHEN THEY HIT BONE THE DRIVER LOST POWER. AS A RESULT, THE GROUND UNIT HAD ANOTHER EZ-IO DRIVER AND THEY WERE ABLE TO COMPLETE THE IO INSERTION. MEDS WERE ADMINISTERED TO THE PT SUCCESSFULLY. IT WAS NOTED THE PT WAS NOT "IN A GOOD PLACE" AND EXPIRED DUE TO HIS CONDITION. THERE WAS NO REPORTED DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239099 EZ-IO POWER DRIVER EZ-IO INTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR