BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHILLER

    MDR report key: 23508108 · Received November 10, 2025

    Report

    Report Number
    8020045-2025-00025
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    September 29, 2025
    Report Date
    November 10, 2025
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    190055315058129
    PMA / PMN Number
    K142803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXIST 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 231212-4011 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. NEITHER THE INVOLVED SAMPLE NOR A PHOTO WAS PROVIDED FOR INVESTIGATION. IT WAS SPECIFIED THAT "THE ELECTRODES HAVE BEEN DISPOSED OF, AND NO PHOTO IS AVAILABLE." REQUESTING A FILLED IN QUESTIONNAIRE AND THE INVOLVED DEVICE WE HAVE BEEN INFORMED THAT [TRANSLATED FROM FRENCH TO GERMAN TO ENGLISH LANGUAGE] "UPON OPENING THE POUCH, THE HELPERS DISCOVERED THAT ONE ELECTRODE WAS UNUSABLE BECAUSE IT WAS STUCK TO THE OTHER. A PLASTIC BACKING FILM WAS MISSING." DURING THE PRODUCTION PROCESS A SILICONIZED LINER IS LAMINATED TO THE PAD LINER. THE ELECTRODES ARE CUT FROM THE LAMINATED LINER LATER IN THE PROCESS. THE PROTECTIVE COVER LINER IS NEVER LIFTED OFF THE PRODUCT DURING PRODUCTION, ASSEMBLY OR PACKAGING. WE CAN DEFINITELY ASSURE THAT THE CONCERNED DEFIBRILLATION SET MET THE SPECIFIED PARAMETERS AT THE TIME OF APPROVAL AND THAT THE DEFECT OR INCIDENT COMPLAINED ABOUT WAS NOT CAUSED BY (B)(6). THE ONLY CONCEIVABLE MOMENT FOR SUCH A FAILURE IS AFTER OPENING THE POUCH, IF AFTER THE REMOVAL OF A SILICONIZED PROTECTIVE LINER ONE ELECTRODE IS FOR WHATEVER REASON NOT ATTACHED TO A PATIENT BUT RATHER - IF TEMPORARILY - ONTO THE OTHER PAD. THE RETAINED SAMPLES OF THE CONCERNED LOT NUMBER SHOWED NO FAILURE. NO OTHER COMPLAINTS OF THAT NATURE HAVE BEEN FILED FOR THIS PRODUCT. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT SDIS DE L'ALLIER, 5, RUE DE L'ARSENAL 03400 YZEURE IN FRANCE. SCHILLER DEFIBRILLATION ELECTRODES MODEL SCHILLER 0-21-0040 FRED EASY PORT (OUR REF.: (B)(4) AND A SCHILLER DEFIBRILLATOR DEFIGARD TOUCH 7 HAD BEEN USED. THE ANSM REPORT STATES THAT [TRANSLATED FROM FRENCH TO GERMAN TO ENGLISH LANGUAGE]: "UPON OPENING THE PACKAGING OF THE DEFIBRILLATION ELECTRODES, THE RESCUERS DISCOVERED THAT ONE ELECTRODE WAS UNUSABLE BECAUSE IT WAS STUCK TO THE SECOND ONE. A PLASTIC FILM WAS MISSING. AS A PRECAUTION, OUR DGT7S ARE EQUIPPED WITH A SECOND SET OF ELECTRODES. THIS ONE (FROM THE SAME BATCH) WAS OPENED, SHOWED NO DEFECTS, AND THE OPERATION COULD BE PERFORMED." FURTHER ON THE ANSM REPORT STATES THAT [TRANSLATED FROM FRENCH TO GERMAN TO ENGLISH LANGUAGE]: "PATIENT'S CURRENT CONDITION: NR MEASURES TAKEN AT THE HEALTHCARE FACILITY TO TREAT THE PATIENT: A SECOND SET OF ELECTRODES (FROM THE SAME BATCH) WAS OPENED; THIS ONE SHOWED NO DEFECTS, ALLOWING THE PROCEDURE TO BE PERFORMED." ON NOVEMBER 05TH, 2025 WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE: WITHIN THE QUESTIONNAIRE NO FURTHER INFORMATION WAS PROVIDED WHICH WAS NOT ALREADY ANNOUNCED IN THE INITIAL REPORT. FURTHER ON THE USER LEFT ALL QUESTIONS REGARDING PATIENT HARM OR RESULTING INJURY UNANSWERED. WE THEREFORE ASSUME THAT NO INJURIES OR DISADVANTAGES OCCURRED TO THE PATIENT. NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807982 SCHILLER MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF87C 231212-4011 190055315058129

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other