BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 6800033 · Received August 17, 2017

    Report

    Report Number
    3011137372-2017-00270
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 8, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW IN THE US. SEVERAL SECTIONS OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, "AS WITH ANY EMERGENCY MEDICAL DEVICE CARRYING A BACKUP IS STRONGLY ADVISED PROTOCOL", "EZ-IO POWER DRIVER LED WITH BLINK RED WHEN THE TRIGGER IS ACTIVATED AND HAS ONLY 10% OF BATTERY LIFE REMAINING", AND "PURCHASE AND REPLACE THE EZ-IO POWER DRIVER WHEN THE RED LED BEGINS BLINKING". A REVIEW OF THE CERTIFICATE OF CONFORMANCE COULD NOT BE CONDUCTED AS THE SERIAL #S IN THE "G" SERIES OF DRIVERS ARE NOT AVAILABLE FOR REVIEW. THE COMPLAINT SAMPLE WAS NEVER RETURNED TO TELEFLEX FOR INVESTIGATION PURPOSES. THE ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE DRIVER STOPS WORKING ONCE AGAINST BONE; THE BATTERY SHOWS GREEN. A BACK UP DRIVER WAS USED TO INSERT THE IO. THE PATIENT'S CONDITION IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE DRIVER STOPS WORKING ONCE AGAINST BONE; THE BATTERY SHOWS GREEN. A BACK UP DRIVER WAS USED TO INSERT THE IO. THE PATIENT'S CONDITION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582328 EZ-IO POWER DRIVER NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL G27132

    Patients

    Seq Age Sex Outcome Treatment
    1