BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 23364577 · Received October 23, 2025

    Report

    Report Number
    8020045-2025-00024
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Report Date
    November 13, 2025
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531506067
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. A VISUAL INSPECTION OF THE RETAINED DEFIBRILLATION ELECTRODE SETS SHOWED NO OBVIOUS DAMAGE. THE RETAINED ELECTRODE CONNECTORS WERE VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. FUNCTIONAL TEST / TEST WITH ELECTRODES STILL ATTACHED TO THE RELEASE LINER: ELECTRICAL TESTING OF THE RETAINED SAMPLES WITH A PHILIPS FR2+ DEFIBRILLATOR STORED AT LL SHOWED THAT THE RETENTION PATTERN ELECTRODES COULD BE INSERTED INTO THE DEFIBRILLATOR'S CONNECTOR SOCKET WITHOUT ANY DEVIATION. THE DEFIBRILLATOR'S SOFTWARE DETECTS THE MAGNET EMBEDDED IN THE CONNECTOR. BASED ON THIS, THE ELECTRODES ARE CHECKED FOR CONTINUITY. SINCE THIS TYPE OF ELECTRODE IS NOT CONNECTED VIA THE GEL APEX TO STERNUM ELECTRODE (THUS NO CLOSED CIRCUIT) NO CONTINUITY OR IMPEDANCE CAN BE MEASURED, RESULTING IN A DEFIBRILLATOR MESSAGE EVEN THOUGH THE ELECTRODE IS PLUGGED INTO THE DEFIBRILLATOR. WITHOUT AN ATTACHED ELECTRODE, THE DEFIBRILLATOR WILL NOT SWITCH FURTHER FROM THE "INSERT AND APPLY ELECTRODE" MODE. THE RETAINED SAMPLE SETS WAS THEN ADHERED ONTO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP. IMMEDIATELY THE MESSAGE "INSERT AND APPLY ELECTRODES" DISAPPEARED FROM THE DEFIBRILLATOR DISPLAY AND AN ECG SIGNAL WAS VISIBLE ON THE DEFIBRILLATOR DISPLAY. WE HAVE SIMULATED A VENTRICULAR FIBRILLATION AND HAVE SUCCESSFULLY SHOCKED TO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP. THE CUSTOMER PROVIDED PICTURES OF THE CONCERNED PRODUCT AND ON THE PICTURES IT IS CLEARLY VISIBLE THAT THE PLUG MAGNET OF THE CONNECTOR WHICH IS NECESSARY FOR THE DETECTION AND RELEASE OF THE DEFIBRILLATOR IS PRESENT. THE CUSTOMER PROVIDED ALSO A VIDEO OF THE REPORTED MALFUNCTION. THE VIDEO CLEARLY SHOWS THAT IT IS NOT A PRODUCT DEFECT. THE USER'S VIDEO SHOWS THAT THE ELECTRODE CONNECTOR WAS PLUGGED INTO A PHILIPS FR2+ DEFIBRILLATOR BUT THE ELECTRODES WERE NOT ATTACHED TO A PATIENT OR A TEST EQUIPMENT. THE USER'S VIDEO CLEARLY SHOWS THE DEFIBRILLATOR DOES NOT SWITCH FURTHER FROM THE "INSERT AND APPLY ELECTRODES" MODE WITHOUT THE ELECTRODES BEING APPLIED TO A PATIENT. THE DEFIBRILLATOR LACKS A FUNCTION TO DETECT AN ELECTRODE THAT IS ONLY INSERTED. WITH THIS DEFIBRILLATOR MODEL, THIS DETECTION ONLY OCCURS AFTER THE ELECTRODES ARE APPLIED TO THE PATIENT, AS THE ELECTRODES ARE PART OF THE ELECTRICAL CIRCUIT. IN THE CUSTOMER VIDEO EVEN THE VOICE PROMPT OF THE DEFIBRILLATOR CLAIMS THAT THE ELECTRODE HAS TO BE "APPLY PADS TO PATIENTS BARE CHEST" AND THEN IT IS CLAIMED THAT THE DEFIBRILLATION ELECTRODES HAVE TO BE PLUGGED IN. THE DEFIBRILLATORS IFU STATES THE FOLLOWING PROCESS: "PAGE 3-2: STEP 1: PREPARATION 1. PLACE THE STICKY SIDE OF EACH PAD ON THE PATIENT'S BARE SKIN, EXACTLY AS SHOWN ON THE DRAWING ON EACH PAD. 2. INSERT THE DEFIBRILLATOR PADS CONNECTOR FIRMLY INTO THE DEFIBRILLATOR'S CONNECTOR SOCKET, INDICATED BY A FLASHING LIGHT AT THE TOP LEFT OF THE FR2+." THE DEFIBRILLATORS IFU STATES ALSO AT THE SECTION "TROUBLESHOOTING DURING PATIENT USE: (PAGE4-10): SYMPTOM: SCREEN AND VOICE PROMPTS: APPLY PADS PRESS PADS FIRMLY POSSIBLE CAUSE: THE DEFIBRILLATOR PADS ARE NOT PROPERLY APPLIED TO THE PATIENT, (...) RECOMMENDED ACTION: MAKE SURE THAT THE DEFIBRILLATOR PADS ARE STICKING COMPLETELY TO THE PATIENTS SKIN." BASED ON THE INVESTIGATION RESULTS WE CAN CONCLUDE THAT THE TESTED ELECTRODES WORKED ACCORDING TO THE SPECIFICATIONS AND WERE FIT FOR USE. WE CONCLUDE THAT THE CLAIMED FAILURE WAS CAUSED BY THE USER NOT WORKING ACCORDING THE INSTRUCTION FOR USE RESPECTIVELY TO BE NOT FAMILIAR WITH THE REQUIREMENTS OF THE INSTRUCTION FOR USE. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALSO AN ADHESION TEST WAS PERFORMED. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE HAVE REQUESTED FURTHER INFORMATION, A QUESTIONNAIRE TO BE COMPLETED AND THE INVOLVED DEVICE BUT HAVE NOT RECEIVED ANY SO FAR. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED INCIDENT. WE WILL THEREFORE PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER SITE IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27NC AND A PHILIPS FR2+ DEFIBRILLATOR HAD BEEN USED. THE INITIAL WAS STATING THAT "I AM ENCOUNTERING SOME ISSUES WITH THE DEFIBRILATOR PADS FOR PHILIPS FR. THE DEFIBRILLATOR DOES NOT RECOGNISE THEM (THE PADS) WHEN PLUGGED IN." WE HAVE REQUESTED FURTHER INFORMATION AND HAVE RECEIVED LATER ON PICTURES AND A VIDEO SHOWING THE CLAIMED FAILURE. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Description of Event or Problem · 0

    ON OCTOBER 3RD, 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER SITE IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27NC AND A PHILIPS FR DEFIBRILLATOR MODEL UNKNOWN HAD BEEN USED. THE INITIAL WAS STATING THAT "I AM ENCOUNTERING SOME ISSUES WITH THE DEFIBRILATOR PADS FOR PHILIPS FR. THE DEFIBRILLATOR DOES NOT RECOGNISE THEM (THE PADS) WHEN PLUGGED IN." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR DESPITE REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729512 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF27NC 240508-4305 19005531506067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other