BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 1672869 · Received April 29, 2010

    Report

    Report Number
    8020045-2010-00002
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Report Date
    April 22, 2010
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K072233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED FOR CONNECTOR FIT. A RETAINED SAMPLES WERE CONNECTED TO A MEDTRONIC LIFEPACK CR PLUS DEFIBRILLATOR AND ALSO APPLIED TO A TEST PERSON. THE DEFIBRILLATION ELECTRODE WAS RECOGNIZED. IT WAS ALSO INSERTED INTO A METAL TEST GAUGE FOR THAT CONNECTOR WITHOUT ANY PROBLEM. NO DEVIATIONS COULD BE DETECTED. THE DEVICE COMPLAINED ABOUT COULD NOT BE RETRIEVED BECAUSE THE CUSTOMER HAD DISCARDED IT. WE WERE NOT ABLE TO REPRODUCE THE REPORTED PROBLEM. AS NO FURTHER INFO HAS BEEN PROVIDED TO US DESPITE REPEATED REQUESTS, NO CONCLUSION CAN BE DRAWN. THE FIRE BRIGADE HAS STATED EXPLICITLY THAT THEY WILL CONTINUE TO WORK WITH OUR PRODUCT AND THAT THE ISSUE IS CLOSED FROM THEIR SIDE (EMAIL FROM (B)(4) ON APRIL 9TH).

    Description of Event or Problem · 1

    ON FEB 10TH, WE HAVE BEEN INFORMED BY DORVIT MEDICAL SA ABOUT A PROBLEM WITH A DEFIBRILLATION ELECTRODE DF20N AT THE EMERGENCY CENTRE (B)(4). ON APRIL 1ST, INFO WAS ADDED POINTING ABOUT A POTENTIAL MALFUNCTION. THE FIRE BRIGADE CLAIMED (TRANSLATED FROM FRENCH) "THE TEAM VSAV HAVE SWITCHED ON A DSA LIFEPACK 500, BRAND MEDTRONIC, AND HAVE PLUGGED IN A PAIR OF THE PADS (ELECTRODES) OF THE BRAND SKINTACT DF20N, BUT THE SDA DEFIBRILLATOR DID NOT RECOGNIZE THE ELECTRODES. THE EQUIPMENT WAS SUCCESSFUL WITH DELIVERING A SHOCK WITH ANOTHER PAIR OF THE ELECTRODES QUICK COMBO OF THE BRAND MEDTRONIC." THE CONCERNED ELECTRODES HAVE BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF20N 90402-9777

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other