BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 1672867 · Received April 29, 2010

    Report

    Report Number
    8020045-2010-00003
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Report Date
    April 22, 2010
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MLN
    PMA / PMN Number
    K072233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED AND RETURNED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY. A RETURNED SAMPLE OF DF27N WAS CONNECTED TO A PHILIPS FR2+ DEFIBRILLATOR AND ALSO APPLIED TO A TEST PERSON (THE LAERDAL FR2 IS AN OEM VERSION OF THE PHILIPS FR2). THE DEFIBRILLATION ELECTRODE WAS RECOGNIZED BY THE DEFIBRILLATOR. NO DEVIATION 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)(6) ON APRIL 09TH).

    Description of Event or Problem · 1

    ON FEB 9TH, WE HAVE BEEN INFORMED BY (B)(6) ABOUT A PROBLEM WITH A DEFIBRILLATION ELECTRODE DF27N AT THE (B)(6). ON APRIL 1ST, INFO WAS ADDED POINTING ABOUT A POTENTIAL MALFUNCTION. THE FIRE BRIGADE CONNECTED A SKINTACT DF27N DEFIBRILLATION ELECTRODE SET WITH A LAERDAL HEARTSTART FR2 (B)(4) AND APPLIED THE ELECTRODES TO A PT. THE FR2 DID NOT RECOGNIZE THE PRESENCE OF THE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MLN LEONHARD LANG GMBH DF27N 90305-0772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other