BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDACARE CORPORATION EZ-IO

    MDR report key: 1387962 · Received May 19, 2009

    Report

    Report Number
    MW5011170
    Event Type
    Malfunction
    Date Received
    May 19, 2009
    Report Date
    April 29, 2009
    Manufacturer
    VIDACARE CORPORTATION
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING THE EZ-IO INTO A M PT'S LEFT TIBIA, THE EZ-IO DRILL LOST POWER AND THE NEEDLE STOPPED GOING INTO THE TIBIA. THIS FAILURE OF POWER RESULTED IN THE LOST OF THE IV SITE. DATE OF USE: 2009. DIAGNOSIS OR REASON FOR USE: IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDACARE CORPORATION EZ-IO EZ-IO HTW VIDACARE CORPORTATION

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY