BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 11002759 · Received December 14, 2020

    Report

    Report Number
    3011137372-2020-00289
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 4, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K180395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE MANUFACTURING DHR FILE WAS REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. 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 WILL 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 DEVICE HISTORY RECORD FOUND THAT THE DRIVER PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 07/2011 AND IS APPROXIMATELY 9.5 YEARS OLD. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. FUNCTIONAL TESTING AND INVESTIGATION ACTIVITIES CANNOT BE CONDUCTED. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. FUNCTIONAL TESTING AND INVESTIGATION ACTIVITIES CANNOT BE CONDUCTED. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 0

    HAD 3 DRIVERS FAIL IN THE FIELD. DIFFERENT SERIAL NUMBERS. APPARENTLY TESTED GREEN COUPLE HOURS BEFORE USE. UPDATE: ONLY TWO UNITS INVOLVED, H08858, K01725.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HAD 3 DRIVERS FAIL IN THE FIELD. DIFFERENT SERIAL NUMBERS. APPARENTLY TESTED GREEN COUPLE HOURS BEFORE USE. UPDATE: ONLY TWO UNITS INVOLVED, H08858, K01725.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470296 EZ-IO POWER DRIVER NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1