BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO DRILL

    MDR report key: 2897772 · Received January 2, 2013

    Report

    Report Number
    2897772
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CHECK OF THE INTRAOSSEOUS (IO) DRILL, IT WAS FOUND NOT TO WORK. THE NURSE TESTED THE DRILL BUT IT WAS NOT OPERATIONAL AT ALL. THE DRILL HAD BEEN OPERATIONAL (ON A PATIENT) WITHIN THE PRIOR WEEK, AND FUNCTIONED APPROPRIATELY. THE DRILL WAS MAINTAINED AS USUAL.======================MANUFACTURER RESPONSE FOR INTRAOSSEOUS DRILL, EZ-IO (PER SITE REPORTER).======================WILL ASSESS DRILL WHEN IT IS RECEIVED. REPLACEMENT DRILL WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258 EZ-IO DRILL NEEDLE FMI VIDACARE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *