BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 4340574 · Received December 10, 2014

    Report

    Report Number
    8020045-2014-00015
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    July 21, 2013
    Report Date
    December 10, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K072233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES AND THE RETURNED CUSTOMER SAMPLE OF THE SAME LOT NUMBER WAS INVESTIGATED VISUALLY. THE RETAINED SAMPLES SHOWED NO DEVIATION. THE RETURNED CUSTOMER SAMPLE SHOWED THE CLAIMED MALFUNCTION. A ROOT CAUSE ANALYSIS SHOWED THAT THE MOST LIKELY CAUSE FOR THE MIX-UP WAS A CABLE MISPLACED BY PERSONNEL OF OUR COMPANY OR OF THE SUPPLIER. IN ADDITION THE CONNECTOR WAS NOT TESTED FOR CONTINUITY AS THIS WOULD HAVE REVEALED THE PRESENCE OF A WRONG CONNECTOR. AFTER INVESTIGATING THIS INCIDENT WE HAVE SET CORRECTIVE AND PREVENTIVE ACTIONS IN OUR PRODUCTION: THE ASSEMBLY LINES HAVE BEEN EQUIPPED WITH CLEARLY MARKED GLASS SURFACE PLATES GUIDING THE WORKFLOW AND THE PLACEMENT OF SEMI-ASSEMBLED ELECTRODE SETS. THE ASSEMBLY LINES HAVE BEEN EQUIPPED WITH SCREENS COMPARTMENTALIZING LINES AND BLOCKING OFF VIEWS TO OTHER LINES AND THUS OPPORTUNITIES FOR DISTRACTION. ASSEMBLY PERSONNEL HAVE BEEN RETRAINED AND BEEN MADE AWARE OF POTENTIAL CONSEQUENCES OF A CONNECTOR MIX-UP IN ADDITION, THE ASSEMBLY OPERATION HAD BEEN MOVED TO A NEW FACILITY IN 2012, MUCH MORE SPACIOUS THAN THE FACILITY OPERATED WHERE IN 2011 THE PRODUCT INVOLVED HAD ASSEMBLED. DURING AN FDA AUDIT FROM 11/17/2014 - 11/20/2014, IT WAS DETERMINED THAT WE FAILED TO REPORT THIS MALFUNCTION TO FDA AT THE TIME. WE DEEPLY REGRET THIS FILE A REPORT TODAY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, WE HAVE BEEN INFORMED OF A MALFUNCTION ON A DEFIBRILLATION ELECTRODE SKINTACT DF20N WITH (B)(6) AMBULANCE SERVICE, (B)(6), IN A MOVING AMBULANCE EN ROUTE TO (B)(6). THE CREW OF AN AMBULANCE WANTED TO APPLY A SKINTACT DEFIBRILLATION ELECTRODE SET DF20N LABELED FOR USE WITH LIFPAK 12 DEFIBRILLATORS ON A PATIENT WHO WAS IN RESPIRATORY ARREST IN PREPARATION FOR FULL CARDIAC ARREST. UPON OPENING THE SEALED POUCH, THEY FOUND THAT THE CONNECTOR AT THE END OF THE ELECTRODE CABLE WAS THE WRONG TYPE, DESPITE THE PACKAGING BEING CORRECT. THIS LED TO A DELAY IN THE PATIENT BEING CONNECTED TO THE DEFIBRILLATOR WHILST THE CREW RECONNECTED USING AN AED MACHINE. ACCORDING TO AN INCIDENT WEB REPORT FORM COMPLETED ON (B)(6) BY (B)(6) AMBULANCE, (B)(6), THE EVENT CAUSED NO HARM/INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797317 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTO MKJ LEONHARD LANG GMBH DF20N 11207-0772

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other