BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 4683931 · Received April 10, 2015

    Report

    Report Number
    3004526033-2015-00024
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 15, 2015
    Report Date
    March 16, 2015
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THEY ATTEMPTED TO USE THE DEVICE THE DRILL STOPPED WORKING. THERE WERE NO ISSUES WITH THE PT AS ANOTHER OPTION WAS USED. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239484 EZ-IO POWER DRIVER EZ-IO INTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1