BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 6123883 · Received November 23, 2016

    Report

    Report Number
    8020045-2016-00026
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    August 7, 2017
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531506432
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. A PRODUCT SPECIALIST VISITED THE COMPLAINING USER FACILITY ON DECEMBER 21. HE WAS ABLE TO VERIFY A FIT PROBLEM WITH THE DEFIBRILLATOR AT SITE AND THE ELECTRODES DF59N BUT NOT WITH DEFIBRILLATORS HE HAD TAKEN WITH HIM AS REFERENCES. IT WAS ALSO NOT POSSIBLE TO REPLICATE THE PROBLEM WITH DEFIBRILLATION ELECTRODES MODEL DF59NC. AFTER THE VISIT, IT WAS ATTEMPTED TO GET THE INVOLVED DEFIBRILLATORS FOR FURTHER INVESTIGATION OF THE SOCKETS. THE COMPLAINANT INFORMED US IN MARCH THAT HE WAS NOT WILLING TO PROVIDE THE DEFIBRILLATOR. IT WAS DECIDED TO PROCURE ZOLL DEFIBRILLATORS OF A MORE RECENT BUILT THAN THE MODELS AT HAND FOR FURTHER INVESTIGATIONS. USABILITY STUDIES CONDUCTED WITH THESE MACHINES AND FURTHER INVESTIGATION REVEALED THAT DEFIBRILLATION ELECTRODES DF59 AND DF59NC WITH A CONNECTOR USED IN ASSEMBLIES TILL 2015 HAVE A POTENTIAL FIT PROBLEM WITH ZOLL AED PLUS MACHINES MANUFACTURED IN RECENT YEARS DUE TO DIMENSIONAL VARIATIONS IN THE DEFIBRILLATORS' ELECTRODE CABLE SOCKET. IT WAS DECIDED TO RECALL THE ELECTRODES AFFECTED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. AS WE WILL SEND A PRODUCT SPECIALIST TO THE COMPLAINING USER FACILITY, WE WILL REPORT FURTHER RESULTS OF OUR INVESTIGATION IN A FOLLOW-UP REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(4), WE HAVE BEEN INFORMED ABOUT A MALFUNCTION INVOLVING A DEFIBRILLATION ELECTRODE SET, MODEL SKINTACT DF59N, AND A ZOLL AED PLUS AT (B)(4). THE INITIAL REPORT STATED THE USER HAD DAMAGED THE CONNECTORS OF TWO DEFIBRILLATORS DURING A TRIAL WHEN ATTEMPTING TO CONNECT THE DEFIBRILLATION ELECTRODES TO TWO ZOLL AED PLUS DEFIBRILLATORS. NO PATIENT WAS HARMED.

    Description of Event or Problem · 1

    ON OCTOBER 19TH, WE HAVE BEEN INFORMED ABOUT A POTENTIAL MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET, MODEL DF59NC, AT AN UNKNOWN CUSTOMER, MOST LIKELY IN (B)(6). THE INITIAL REPORT STATED THE USER HAD DAMAGED THE CONNECTORS OF TWO DEFIBRILLATORS WHEN ATTEMPTING TO CONNECT THE DEFIBRILLATION ELECTRODE. ON OCTOBER 25TH, WE RECEIVED A CORRECTION TO THE EXTENT THAT THE ELECTRODE MODEL INVOLVED WAS DF59N AND NOT DF59NC. NO PATIENT WAS HARMED. WE WILL SEND A PRODUCT SPECIALIST TO THE COMPLAINING USER SITE TO INVESTIGATE THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776363 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF59N 50403-0772 19005531506432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other