BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3012752-001 QPACE 1/P 10/B 50/

    MDR report key: 3636110 · Received November 25, 2013

    Report

    Report Number
    1219103-2013-00070
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 30, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THEY ATTEMPTED TO USE THE PACING FUNCTION WITH THEIR LIFEPAK 10 DEFIBRILLATOR/MONITOR. THE CUSTOMER REPORTS THAT THEY CONNECTED THE QUIK-PACE ELECTRODES TO A PT, CONNECTED THE LP10 PACER CABLE TO THE QUIK-PACE ELECTRODES BUT THE PACER DID NOT START BECAUSE NO CONTACT TO THE PT WAS RECOGNIZED BY THE DEVICE. THE CUSTOMER CHECKED THE QUIK-PACE ELECTRODE CONNECTOR AND THE PACER CABLE AND FOUND THAT THE CONTACT OF THE QUIK-PACE ELECTRODES WAS COVERED BY AN ADHESIVE LABEL. THEN THE CUSTOMER REMOVED THE ADHESIVE FROM THE CONTACTS AND AFTER 1-2 MINUTES, THE PT WAS TREATED WITH PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614506 3012752-001 QPACE 1/P 10/B 50/ DEFIBRILLATION ELECTRODES MKJ COVIDIEN PM10011 223744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK