BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 24256049 · Received February 4, 2026

    Report

    Report Number
    8020045-2026-00005
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 10, 2026
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531506388
    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 NUMBERS HAVE BEEN INSPECTED VISUALLY AND FOR THEIR FITTING OF THE MAGNET IN THE CONNECTOR SOCKET. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. ON JANUARY 12, 2026, WE HAVE BEEN INFORMED THAT THE CONCERNED SAMPLE WILL BE FORWARDED TO LEONHARD LANG. ON FEBRUARY 13, 2026, WE HAVE BEEN INFORMED BY THE CARRIER THAT THE CONCERNED SAMPLE HAD BEEN LOST. BASED ON THE PROVIDED CUSTOMER PICTURES THE CLAIMED DEFECT CAN BE CAUSED BY TWO DIFFERENT POSSIBLE FAILURES. 1) THE MAGNET HAS RAISED OUT OF ITS SOCKET. 2) THE INTENDED MAGNET IS CORRECT IN THE SOCKET. A SECOND MAGNET IS STUCK TO IT AND THEREFORE PROTRUDES. INTERNAL TESTS HAVE BEEN CONDUCTED TO TRY AND REMOVE THE MAGNET FROM ITS SOCKET. THE TESTS HAVE SHOWN THAT CONSIDERABLE FORCE WAS REQUIRED TO DISLODGE THE MAGNET. THE PLUG HAD TO BE REPEATEDLY STRUCK AGAINST A HARD PLATE WITH INCREASED FORCE UNTIL THE MAGNET FINALLY FELL OUT. TO EVALUATE THE SECOND POSSIBLE CAUSE, A SECOND MAGNET WAS PLACED OVER THE EXISTING ONE. THE MAGNETIC FORCE HOLDS THE SECOND MAGNET IN PLACE. COMPARING THE CUSTOMER SAMPLE PICTURE WITH THE INTERNALLY REPRODUCED CABLE WITH TWO MAGNETS, THEY APPEAR VERY SIMILAR. BASED ON THE THICKNESS OF THE PROTRUDING MAGNET, IT CAN BE ASSUMED THAT IT IS MOST LIKELY THAT A SECOND MAGNET STUCK ON TOP OF THE EXISTING ONE. IT IS THEREFORE MOST LIKELY THAT AN ADDITIONAL MAGNET ADHERED TO THE INTENDED MAGNET. IT IS UNCLEAR WHERE IN THE WHOLE PRODUCTION THE ADDITIONAL MAGNET WAS INTRODUCED TO THE PLUG. HOWEVER WE ASSUME THAT IT IS CONSIDERED TO BE MOST LIKELY THAT A LOOSE MAGNET WAS INTRODUCED DURING THE SUPPLIER'S CABLE PRODUCTION PROCESS. WE HAVE TESTED, A CONNECTOR WITH TWO MAGNETS FOR PLUGGABILITY. IT WAS FOUND THAT, DESPITE THE ADDITIONAL MAGNET, THE CONNECTOR COULD BE FULLY INSERTED INTO THE SOCKET TESTER IN THE PRODUCTION LINE OF LEONHARD LANG. ADDITIONALLY WE ALSO HAVE TESTED THE PLUGGABILITY WITH THE PHILIPS HEARTSTART FR3 AND PHILIPS HEARTSTART FR2+ AEDS, THE CONNECTOR WITH TWO MAGNETS COULD BE FULLY INSERTED INTO THE SOCKET OF THESE DEFIBRILLATORS. USING AN ADAPTER CABLE A FULL PLUG IN WAS NOT POSSIBLE WITH TWO MAGNET STUCK TO THE PLUG. THE ADDITIONAL MAGNET REMAINED BLOCKED ON AN EDGE OF THE ADAPTER CABLE CONNECTOR. HOWEVER, WITH INCREASED FORCE, THE ADDITIONAL MAGNET COULD BE PUSHED AWAY FROM THE UNDERLYING MAGNET, ALLOWING FOR FULL INSERTION. A CAPA WAS INITIATED FOR INTRODUCING ACTIONS TO RELIABLY DETECT A SECOND MAGNET ON A PLUG IN THE PRODUCTION OF LEONHARD LANG USING THE PLUG TESTER AS ALL CABLES ARE 100% PLUGGED INTO THE TEST DEVICE. REVIEWING THE COMPLAINT DATABASE IN THE LAST 5 YEARS NO COMPARABLE COMPLAINT WAS FILED. WE THEREFORE ASSUME THIS COMPLAINT TO BE A FREAK ACCIDENT. HOWEVER THE IFU STATES THAT "ALWAYS KEEP A SECOND PACK OF ELECTRODES WITH THE DEFIBRILLATOR". WE CONCLUDE A MANUFACTURING SINGLE ERROR PROBLEM LED TO THE INCIDENT. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBERS HAVE BEEN INSPECTED VISUALLY AND FOR THEIR FITTING OF THE MAGNET IN THE CONNECTOR SOCKET. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE HAVE REQUESTED A FILLED IN QUESTIONAIRE AND THE INVOLVED DEVICE FOR FURTHER INVESTIGATION. WE WILL PROVIDE FURTHER INFORMATION, INVESTIGATION RESULTS AND ANY CONCLUSION IN A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    ON JANUARY 12TH, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE MAGNET ON THE CONNECTOR RAISED SO WOULD NOT SLIP IN TO DEFIB". ADDITIONALLY WE HAVE RECEIVED TWO PICTURES SHOWING THE CLAIMED FAILURE. ON ONE OF THE TWO PICTURES IT IS CLEARLY VISIBLE THAT THE MAGNETIC INSERT OF THE PLUG IS PROTRUDING OUT OF ITS SOCKET. ON THE OTHER PICTURE THE PLUG IS ONLY SEEN IN THE TOP SIGHT. NO VISUAL DAMAGES OR OTHER DEVIATIONS OF THE PLUG CAN BE SEEN ON THE CUSTOMER PICTURES. IT WAS ALSO SPECIFIED THAT THE CONCERNED SAMPLE WILL BE AVAILABLE FOR FURTHER INVESTIGATION. WE ARE THEREFORE AWAITING THE CONCERNED SAMPLE. WE HAVE REQUESTED A FILLED IN QUESTIONNAIRE AND THE INVOLVED DEVICE FOR FURTHER INVESTIGATION. ON FEBRUARY 26TH, 2026 WE HAVE RECEIVED A FANNIN QUESTIONNAIRE FORM STATING THAT THE CONCERNED DEFIBRILLATION ELECTRODES HAVE BEEN USED "FOR DEFIBRILLATION DURING PERI-ARREST." IT WAS ALSO REPORTED THAT THE THEY "OPENED, RELEASED ISSUE, DISCONNECTED" . THE PRODUCT PROBLEM WAS DESCRIBED AS "MAGNET ON CONNECT (PAD SIDE) RAISED SO WAS UNABLE TO ATTACH TO THE DEFIBRILLATOR. ALTERNATIVE PADS FOUND AND SWAPPED OUT, PT [PATIENT] FINE + CASE FINISHED." NO SERIOUS INJURY/DEATH HAD HAPPENED AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ON JANUARY 12, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE MAGNET ON THE CONNECTOR RAISED SO WOULD NOT SLIP IN TO DEFIB". ADDITIONALLY, WE HAVE RECEIVED TWO PICTURES SHOWING THE CLAIMED FAILURE. ON ONE OF THE TWO PICTURES, IT IS CLEARLY VISIBLE THAT THE MAGNETIC INSERT OF THE PLUG IS PROTRUDING OUT OF ITS SOCKET. ON THE OTHER PICTURE, THE PLUG IS ONLY SEEN IN THE TOP SIGHT. NO VISUAL DAMAGES OR OTHER DEVIATIONS OF THE PLUG CAN BE SEEN ON THE CUSTOMER PICTURES. IT WAS ALSO SPECIFIED THAT THE CONCERNED SAMPLE WILL BE AVAILABLE FOR FURTHER INVESTIGATION. WE ARE THEREFORE AWAITING THE CONCERNED SAMPLE. WE WILL PROVIDE A FOLLOW UP REPORT ONCE ANY FURTHER INFORMATION WILL BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317361 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH SKINTACT DF27N 240725-4044 19005531506388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other