BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 5166115 · Received October 21, 2015

    Report

    Report Number
    3004526033-2015-00088
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    September 21, 2015
    Report Date
    October 9, 2015
    Manufacturer
    VIDACARE
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED: THE COMPLAINT THAT THE DRIVER WAS UNABLE TO COMPLETE AN INSERTION WAS CONFIRMED. THE DRIVER POWERED OFF DURING THE ATTEMPTED INSERTION DUE TO BATTERY DEPLETION. ALTHOUGH IT COULD NOT BE DETERMINED WHY THE DRIVER LED DID NOT SWITCH TO RED; TELEFLEX HAS OPENED (B)(4) TO INVESTIGATE FURTHER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT LETTERS HAD BEEN ENGRAVED INTO THE HOUSING. NO OTHER PHYSICAL DAMAGE WAS OBSERVED. THE DRIVER HAD NO POWER WHEN THE TRIGGER WAS PRESSED. THE TRIGGER GUARD WAS PRESENT. FUNCTIONAL TESTING WAS PERFORMED AND THE MOTOR WAS CONNECTED TO DC POWER SUPPLY. WHEN THE TRIGGER WAS PRESSED, THE LED WAS GREEN. MEASUREMENTS WERE TAKEN OF THE OPEN AND CLOSED CIRCUIT VOLTAGES AND IT WAS DETERMINED THAT THE BATTERIES WERE DEPLETED. A REVIEW OF THE CERTIFICATE OF CONFORMANCE (C OF C) FOUND THAT THE DRIVER PASSED ALL RELEASE CRITERIA. THIS DRIVER WAS MANUFACTURED IN 04/2012 AND IS APPROXIMATELY 3 YEARS OLD. THE COMPLAINT THAT THE DRIVER HAD NO POWER AND DISPLAYED A GREEN LED WAS CONFIRMED. THE CAUSE OF THE DRIVER HAVING NO POWER WAS THAT THE BATTERIES WERE DEPLETED. BASED ON THE AVAILABLE INFORMATION, IT COULD NOT BE DETERMINED WHY THE LED DID NOT TURN RED AND WHY THE CHARGE COUNT WAS LOW. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR THIS ISSUE. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN INTERVENTION TOOK PLACE IN AN AMBULANCE RESPONSE TO A PATIENT THAT SUFFERED FROM A CARDIOPULMONARY ARREST IN A BIOLOGY LAB. THE PATIENT WENT THROUGH A NOFLOW PERIOD WHICH LASTED 5 MIN. WHEN EMERGENCY RESPONDERS ARRIVED THE PATIENT WAS IN CARDIOPULMONARY ARREST AND INITIAL CARDIAC RHYTHM OF BRADYCARDIA (20BPM). THREE PERIPHERAL VENOUS ACCESS INSERTIONS FAILED. AN ESZ-IO DRIVER WAS THEN USED AND THERE WAS NO REACTION FROM THE EZ-IO DRIVER WHEN THE TRIGGER WAS PULLED. THE DRIVER WAS THEN TESTED AND THERE WAS A WEAK ROTATION WHICH LASTED FOR A BRIEF MOMENT. THE PATIENT'S CONDITION IS NOT REPORTED AT THIS TIME. NO PATIENT DEATH REPORTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN INTERVENTION TOOK PLACE IN AN AMBULANCE RESPONSE TO A PATIENT THAT SUFFERED FROM A CARDIOPULMONARY ARREST IN A BIOLOGY LAB. THE PATIENT WENT THROUGH A NOFLOW PERIOD WHICH LASTED 5 MIN. WHEN EMERGENCY RESPONDERS ARRIVED THE PATIENT WAS IN CARDIOPULMONARY ARREST AND INITIAL CARDIAC RHYTHM OF BRADYCARDIA (20BPM). THREE PERIPHERAL VENOUS ACCESS INSERTIONS FAILED. AN ESZ-IO DRIVER WAS THEN USED AND THERE WAS NO REACTION FROM THE EZ-IO DRIVER WHEN THE TRIGGER WAS PULLED. THE DRIVER WAS THEN TESTED AND THERE WAS A WEAK ROTATION WHICH LASTED FOR A BRIEF MOMENT. THE PATIENT'S CONDITION IS NOT REPORTED AT THIS TIME. NO PATIENT DEATH REPORTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN INTERVENTION TOOK PLACE IN AN AMBULANCE RESPONSE TO A PATIENT THAT SUFFERED FROM A CARDIOPULMONARY ARREST IN A BIOLOGY LAB. THE PATIENT WENT THROUGH A NOFLOW PERIOD WHICH LASTED 5 MIN. WHEN EMERGENCY RESPONDERS ARRIVED THE PATIENT WAS IN CARDIOPULMONARY ARREST AND INITIAL CARDIAC RHYTHM OF BRADYCARDIA (20BPM). THREE PERIPHERAL VENOUS ACCESS INSERTIONS FAILED. AN ESZ-IO DRIVER WAS THEN USED AND THERE WAS NO REACTION FROM THE EZ-IO DRIVER WHEN THE TRIGGER WAS PULLED. THE DRIVER WAS THEN TESTED AND THERE WAS A WEAK ROTATION WHICH LASTED FOR A BRIEF MOMENT. THE PATIENT'S CONDITION IS NOT REPORTED AT THIS TIME. NO PATIENT DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695931 EZ-IO POWER DRIVER EZ-IO INTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR