BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 10604526 · Received September 30, 2020

    Report

    Report Number
    8020045-2020-00021
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Report Date
    October 13, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    190005531502455
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. AFTER SEVERAL REQUESTS FOR FURTHER INFORMATION THE INITIAL REPORTER HAS STATED: "I OPENED THE AFFECTED SET OF PADS AND WHEN THE PADS WERE REMOVED FROM TOUCHING EACH OTHER THE FAULT SUBSIDED. I BELIEVE THE PROBLEM WAS BECAUSE THE METAL SIDES OF THE ELECTRODES WERE TOUCHING." WE HAD NO CHANCE TO INVESTIGATE THIS THEORY AS THE INVOLVED PRODUCT HAS NOT YET BEEN RETURNED TO US. AS NO METAL IS EXPOSED IN AN INTACT ELECTRODE, IT IS NOT CONCEIVABLE HOW METAL ELEMENTS OF THE TWO ELECTRODES MIGHT HAVE TOUCHED. AS NEITHER ANY FURTHER INFORMATION NOR THE DEVICE INVOLVED HAVE BEEN MADE AVAILABLE DESPITE REPEATED REQUESTS WE CLOSE THE INVESTIGATION. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CUSTOMER PROBLEM.

    Description of Event or Problem · 0

    ON AUGUST 31TH, 2020, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT NJP MEDICAL LIMITED IN UK. A DEFIBRILLATION ELECTRODE SET (MODEL SKINTACT DF28NC) WAS ABOUT TO BE CONNECTED TO A ZOLL E SERIES DEFIBRILLATOR. MR. (B)(6), WHO HAD FILED THE INITIAL COMPLAINT, STATED: ""HELLO, I HAVE A SET OF ZOLL PADS AND WHEN PLUGGED INTO THE ZOLL E SERIES THEY ARE SIMULATING VF [VENTRICULAR FIBRILLATION] WHEN THEY ARE STILL IN PACKAGE." THERE APPEARS TO HAVE BEEN NO HARM CAUSED TO A PATIENT.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY, AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. AFTER SEVERAL REQUESTS FOR FURTHER INFORMATION, THE INITIAL REPORTER HAS STATED, "I OPENED THE AFFECTED SET OF PADS AND WHEN THE PADS WERE REMOVED FROM TOUCHING EACH OTHER THE FAULT SUBSIDED. I BELIEVE THE PROBLEM WAS BECAUSE THE METAL SIDES OF THE ELECTRODES WERE TOUCHING." WE HAD NO CHANCE TO INVESTIGATE THIS THEORY AS THE INVOLVED PRODUCT HAS NOT YET BEEN RETURNED TO US. AS NO METAL IS EXPOSED IN AN INTACT ELECTRODE, IT IS NOT CONCEIVABLE HOW METAL ELEMENTS OF THE TWO ELECTRODES MIGHT HAVE TOUCHED. WE HAVE REQUESTED FURTHER INFORMATION, AND THE INVOLVED DEVICE FOR FURTHER INVESTIGATION. ONCE WE WILL RECEIVE ANY WE WILL PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT NJP MEDICAL LIMITED IN UK. A DEFIBRILLATION ELECTRODE SET (MODEL SKINTACT DF28NC) WAS ABOUT TO BE CONNECTED TO A ZOLL E SERIES DEFIBRILLATOR. MR. NOAH PHILLIPS, WHO HAD FILED THE INITIAL COMPLAINT, STATED, "HELLO, I HAVE A SET OF ZOLL PADS AND WHEN PLUGGED INTO THE ZOLL E SERIES THEY ARE SIMULATING VENTRICULAR FIBRILLATION WHEN THEY ARE STILL IN PACKAGE." THERE APPEARS TO HAVE BEEN NO HARM CAUSED TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074913 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF28NC 180525-0975 190005531502455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other