BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 24051419 · Received January 13, 2026

    Report

    Report Number
    8020045-2026-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Report Date
    January 13, 2026
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    2900553150168
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE POSSIBLE CONCERNED LOT NUMBERS 250930-0779, 251013-0773 AND 250416-4041 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE HAVE REQUESTED FURTHER INFORMATION ON THE MALFUNCTION, A FILLED IN QUESTIONNAIRE AND THE CONCERNED SAMPLES. BUT NONE HAVE BEEN RECEIVED SO FAR. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED ANY.

    Description of Event or Problem · 0

    ON DECEMBER 16TH, 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) IN GERMANY. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF28N ZOLL AND A ZOLL DEFI R SERIES HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "DEFIBRILLATOR: ZOLL R-SERIES CABLE 8009-0750 WAS USED FOR THE FIRST INCIDENT, THEN SWITCHED TO 8009-0749, BUT THE PROBLEM PERSISTED. APPLICATION SITE: RIGHT POSTERIOR SHOULDER, NEAR THE SCAPULA LEFT SIDE OF THE THORAX OCCURRED DURING SURGERY WITH THE THORAX OPEN." FURTHER ON IT WAS STATED THAT "DF28 FAILED TO TRIGGER AT LEAST THREE TIMES WITH DIFFERENT PATIENTS AND DIFFERENT DEFIBRILLATORS. PROBLEMS ALSO OCCURRED IN THE CARDIAC CATHETERIZATION LAB DURING SURGERY." THE USER WAS NOT ABLE TO SPECIFY A SPECIFIC AND CONCERNED LOT NUMBER. THREE LOT NUMBERS HAD BEEN SUPPLIED TO THE USER WHICH ARE POSSIBLY CONCERNED LOT NUMBERS: 250930-0779, 251013-0773 AND 250416-4041. REQUESTING FURTHER INFORMATION, A FILLED IN QUESTIONNAIRE AND THE CONCERNED SAMPLES WE HAVE BEEN INFORMED THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "THE PATIENT IS DOING WELL; NOTHING HAPPENED BECAUSE THE ORIGINAL ZOLL DEFIBRILLATOR SPOONS COULD BE USED INTRAOPERATIVELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115032 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF28N 250930-0779 2900553150168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other