BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS CORPATCH

    MDR report key: 24187179 · Received January 27, 2026

    Report

    Report Number
    8020045-2026-00004
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 4, 2026
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    29005531002481
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXISTS FOR IT. HOWEVER, DEVICES MADE USING A SIMILAR DESIGN ARE SOLD IN THE US. WE ARE THEREFORE REPORTING THIS INCIDENT. RETAINED SAMPLES OF THE CONCERNED LOT NUMBER 250418-4896 HAVE BEEN INSPECTED VISUALLY, ELECTRICALLY AND TESTED FOR THE ADHESION. ALL TESTED ELECTRODES WERE WITHIN LIMITS; NO FAILURE COULD BE DETECTED. ON JANUARY 14TH, 2026 THE INVOLVED DEVICE WAS RECEIVED IN AN OPEN POUCH. IT WAS DISINFECTED AND THEN INSPECTED. A VISUAL INSPECTION OF THE DEFIBRILLATION ELECTRODE SET SHOWED NO OBVIOUS DAMAGE. THE CONNECTOR AND THE CABLE OF THE INVOLVED ELECTRODE SET WAS ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED USING A MULTIMETER TO TEST FOR ELECTRICAL CONTINUITY. A CONTINUITY TEST WAS PERFORMED TO CHECK THE ELECTRICAL CONTINUITY BETWEEN THE CONNECTOR (PIN APEX AND STERNUM PAD) AND THE ELECTRODE (GEL AREA OF APEX AND STERNUM ELECTRODE). THE SAMPLE PAIR WAS WITHIN LIMITS. THE CONCERNED SAMPLE HAS BEEN SENT TO UNIVERSITY HOSPITAL IN (B)(6) FOR X-RAY AND COMPUTER TOMOGRAPHY INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE FURTHER INVESTIGATION RESULTS HAVE BECOME AVAILABLE AND FURTHER INFORMATION FROM THE USER ARE AVAIALBLE.

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXISTS FOR IT. HOWEVER, DEVICES MADE USING A SIMILAR DESIGN ARE SOLD IN THE US. WE ARE THEREFORE REPORTING THIS INCIDENT. RETAINED SAMPLES OF THE CONCERNED LOT NUMBER 250418-4896 HAVE BEEN INSPECTED VISUALLY, ELECTRICALLY AND TESTED FOR THE ADHESION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON JANUARY 14TH, 2026 THE INVOLVED DEVICE WAS RECEIVED IN AN OPEN POUCH. IT WAS DISINFECTED AND THEN INSPECTED. A VISUAL INSPECTION OF THE DEFIBRILLATION ELECTRODE SET SHOWED NO OBVIOUS DAMAGE. THE CONNECTOR AND THE CABLE OF THE INVOLVED ELECTRODE SET WAS ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED USING A MULTIMETER TO TEST FOR ELECTRICAL CONTINUITY. THE TEST WAS PERFORMED TO CHECK THE ELECTRICAL CONTINUITY BETWEEN THE CONNECTOR (PIN APEX AND STERNUM PAD) AND THE ELECTRODE (GEL AREA OF APEX AND STERNUM ELECTRODE). THE SAMPLE PAIR WAS WITHIN LIMITS. WE HAVE FURTHER INVESTIGATED THE INVOLVED DEFIBRILLATION ELECTRODE SET AT (B)(6). THERE AN X-RAY INVESTIGATION WAS CARRIED OUT ON ALL METAL PARTS OF THE DEFIBRILLATION ELECTRODE SET. ON JANUARY 27TH, 2023 WE HAVE RECIEVED THE X-RAY INVESTIGATION RESULTS / PICTURES AND NO FAILURE OR ROOT CAUSE CAN BE DETECTED. WE THEREFORE HAVE FURTHER INVESTIGATED THE INVOLVED DEFIBRILLATION ELECTRODE SET WITH A COMPUTER TOMOGRAPHY. THE CT RESULTS OF THE ELECTRODE SET INVOLVED SHOWED NO ANOMALIES OR DEVIATIONS. AFTERWARDS AN ELECTRICAL PERFORMANCE TEST WAS CARRIED ON. THE INVOLVED ELECTRODE SETS WAS ADHERED ONTO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP AND CONNECTED TO THE GS CORPULS C3 DEFIBRILLATOR. THE DEFIBRILLATOR WAS SWITCHED ON AND THE PADS WERE IMMEDIATLY RECOGNIZED BY THE DEFIBRILLATOR 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. IN TOTAL 2 TIMES HAVE BEEN SHOCKED TO THE DEFIBRILLATION ELECTRODES IN AUTOMATIC AND MANUAL MODE. IT WAS NOT POSSIBLE TO OBSERVE THE CLAIMED FAILURE WHEN INVESTIGATING THE CONCERNED CUSTOMER SAMPLE. WE WERE NOT ABLE DETECT ANY FAILURE. NO FURTHER CONCLUSION CAN BE DRAWN. HOWEVER, THE IFU STATES THAT "ALWAYS KEEP A SECOND PACK OF ELECTRODES WITH THE DEFIBRILLATOR". WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.

    Description of Event or Problem · 0

    ON JANUARY 02ND, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT JOHANNITER-UNFALL-HILFE E.V. REGINALVERBAND OBERSCHABEN-BODENSEE IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE 05120.4 CORPATCH EASY PRO (MODEL DF90NC) AND A GS STEMPLE C3 DEFIBRILLATOR HAVE BEEN USED. THE INITIAL REPORT WAS STATING THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "DURING AN EMERGENCY CALL, DEFIBRILLATION ELECTRODES WERE APPLIED TO AN UNRESPONSIVE PATIENT. THE DEFIBRILLATOR DID NOT INITIALLY RECOGNIZED THESE ELECTRODES, WHICH CAUSED A SLIGHT DELAY IN DIAGNOSIS. THE PATIENT SHOWED SIGNS OF HAVING BEEN DEAD FOR SOME TIME. WHEN THE ECG ELECTRODES WERE APPLIED, A CONTINUOUS FLAT LINE WAS VISIBLE. AFTER USE, THE DEFIBRILLATION ELECTRODES USED WERE TAKEN TO THE RESTRICTED STORAGE AREA, INCLUDING THEIR PACKAGING. THE DEVICE WAS CHECKED SEVERAL TIMES AND WORKED PERFECTLY WITH OTHER PAIRS OF ELECTRODES. IT WAS NOTICEABLE THAT THE DEFIBRILLATOR ONLY FAILED TO RECOGNIZE THE PAIR OF ELECTRODES IN QUESTION. WHEN THE CABLES WERE MOVED, THE ELECTRODE WAS TEMPORARILY DETECTED, INDICATING A POSSIBLE CONTACT OR CABLE DEFECT. WE HAVE ALREADY SUBMITTED A REPORT TO THE BFARM IN ACCORDANCE WITH THE GUIDELINES." A QUESTIONNAIRE ON INCIDENTS INVOLVING DEFIBRILLATION ELECTRODES AND A REQUEST FOR THE SAMPLE INVOLVED WAS SENT OUT ON JANUARY 02ND, 2026. ADDITIONALLY ON JANUARY 7TH, 2026, FURTHER INFORMATION WAS REQUESTED FROM THE USER BY TELEPHONE AND EMAIL. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Description of Event or Problem · 0

    ON JANUARY 02ND, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE 05120.4 CORPATCH EASY PRO (MODEL DF90NC) AND A GS STEMPLE C3 DEFIBRILLATOR HAVE BEEN USED. THE INITIAL REPORT WAS STATING THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "DURING AN EMERGENCY CALL, DEFIBRILLATION ELECTRODES WERE APPLIED TO AN UNRESPONSIVE PATIENT. THE DEFIBRILLATOR DID NOT INITIALLY RECOGNIZED THESE ELECTRODES, WHICH CAUSED A SLIGHT DELAY IN DIAGNOSIS. THE PATIENT SHOWED SIGNS OF HAVING BEEN DEAD FOR SOME TIME. WHEN THE ECG ELECTRODES WERE APPLIED, A CONTINUOUS FLAT LINE WAS VISIBLE. AFTER USE, THE DEFIBRILLATION ELECTRODES USED WERE TAKEN TO THE RESTRICTED STORAGE AREA, INCLUDING THEIR PACKAGING. THE DEVICE WAS CHECKED SEVERAL TIMES AND WORKED PERFECTLY WITH OTHER PAIRS OF ELECTRODES. IT WAS NOTICEABLE THAT THE DEFIBRILLATOR ONLY FAILED TO RECOGNIZE THE PAIR OF ELECTRODES IN QUESTION. WHEN THE CABLES WERE MOVED, THE ELECTRODE WAS TEMPORARILY DETECTED, INDICATING A POSSIBLE CONTACT OR CABLE DEFECT. WE HAVE ALREADY SUBMITTED A REPORT TO THE BFARM IN ACCORDANCE WITH THE GUIDELINES." A QUESTIONNAIRE ON INCIDENTS INVOLVING DEFIBRILLATION ELECTRODES AND A REQUEST FOR THE SAMPLE INVOLVED WAS SENT OUT ON JANUARY 02ND, 2026. ADDITIONALLY ON JANUARY 7TH, 2026, FURTHER INFORMATION WAS REQUESTED FROM THE USER BY TELEPHONE AND EMAIL. WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONAIRE. WITHIN THIS QUESTIONAIRE IT WAS STATED THAT THE INCIDENT OCCURRED IN THE PATIENT'S APARTMENT. THE 90-YEAR-OLD MALE PATIENT WAS DESCRIBED AS OF SLIM BUILD BODY WITH A NORMAL SKIN AND MINIMAL BODY HAIR. THE PATIENT HAD NO RELEVANT PRE-EXISTING CONDITIONS, ALLERGIES, OR MEDICATION-RELATED FACTORS. THE SKIN HAD NOT BEEN SPECIALLY CLEANED, DRIED, SHAVED, OR DISINFECTED, AND NO SKIN LOTIONS HAD BEEN USED. THERE WERE NO PRE-EXISTING SKIN LESIONS. THE ELECTRODES WERE FULLY ADHERING TO THE SKIN; THERE WAS NO DETACHMENT, GEL RESIDUES, FLUID ACCUMULATION, SWELLING, WRINKLES, BLISTERS, OR ELECTRICAL DISCHARGE. NO INJURIES OR SKIN ABNORMALITIES WERE OBSERVED. A REPOSITIONING OF THE ELECTRODES WAS NOT NECESSARY. THE PATIENT WAS LYING ON THE CARPET THROUGHOUT THE PROCEDURE. A GS STEMPLE C3 DEFIBRILLATOR IN BIPHASIC MODE, SEMI-AUTOMATIC PROGRAM HAD BEEN USED. IT WAS ALSO STATED THAT NO ADAPTER WAS USED. THE USER WAS A PARAMEDIC. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247645 GS CORPATCH MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF90NC 250418-4896 29005531002481

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Other