BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS

    MDR report key: 14839596 · Received June 28, 2022

    Report

    Report Number
    8020045-2022-00018
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    May 29, 2022
    Report Date
    October 3, 2022
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531505302
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO 510 (K) AND NO PMA EXIST FOR THIS PRODUCT. IT IS NOT MARKETED IN THE USA. HOWEVER, DEVICES MADE USING A SIMILAR DESIGN ARE SOLD IN THE US. WE ARE THEREFORE REPORTING THIS INCIDENT. RETAINED SAMPLES OF THE POSSIBLE CONCERNED LOT NUMBERS (220216-4012; 210602-4015; 211129-4019) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE INVOLVED DEFIBRILLATION SET HAVE NOT BEEN MADE AVAILABLE TO US. WE ASSUME THE CONCERNED DEFIBRILLATION SET WAS DISCARDED AFTERWARDS AS IT WAS SPECIFIED: THE ELECTRODES USED CAN NO LONGER BE FOUND. ON JUNE 21ST, 2022 WE HAVE RECEIVED THREE ORIGINAL CLOSED POUCHES OF THE POSSIBLE CONCERNED LOT NUMBERS 220216-4012; 210602-4015; 211129-4019 FROM THE USER FOR FURTHER INVESTIGATION. THE RETURNED SAMPLES HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. AN ELECTRICAL CONTINUITY TEST USING A MULTIMETER FOR RETURNED DEFIBRILLATION SETS WAS PERFORMED ON ALL METAL COMPONENTS: THE CONNECTOR, THE CABLE, THE RIVET AND THE ELECTRODE ITSELF. NO ELECTRICAL FAILURE OF THE METALLIC COMPONENTS WAS DETECTED. AFTERWARDS THE RETURNED DEFIBRILLATION SETS WERE TESTED FOR THE FUNCTION ON A GS CORPULS 3 DEFIBRILLATOR. THE RETURNED DEFIBRILLATION ELECTRODE SETS HAVE BEEN RECOGNIZED IMMEDIATELY BY THE DEFIBRILLATOR AND SIMULATING A PATIENT INCIDENT ON THE TEST DEVICE FLUKE IMPULSE 7000DP. ALSO A SIMULATED SHOCK ON BOTH TESTED RETURNED DEFIBRILLATION SETS WAS SUCCESSFULLY. THE PACING/STIMULATION MODE WAS ALSO TESTED. NO ABNORMALITIES WERE FOUND HERE EITHER. IN ANY CASE, WE HAVE RECEIVED SEVERAL COMPLAINTS WITH SIMILAR CONTENTS REGARDING THIS DEFIBRILLATION ELECTRODE MODEL. THESE ARE SUBJECT OF SEPARATE REPORTS TO FDA. AS THE CONCERNED PRODUCT INVOLVED IN THIS INCIDENT WAS DISCARDED NO CONCLUSION REGARDING THE CAUSE OF THE MALFUNCTION CAN BE DRAWN. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    ON JUNE 03RD, 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT RESCUE SERVICE RETTUNGSDIENST DES KREISES SCHLESWIG-FLENSBURG IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR (CORPULS C3) HAD BEEN USED. THE INITIAL REPORT IS STATING THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: DURING A RESUSCITATION, THE SITUATION AROSE THAT THE DEFIBRILLATOR DID NOT RECOGNIZE THE TYPE OF DEFIBRILLATION ELECTRODE (CORPATCH EASY PRECON. ADULT/CHILD SLIM MODULE) FOR DEFIBRILLATION. BEFORE EACH DEFIBRILLATION, THE DEVICE ASKED WHETHER IT WAS A "TEST ASSIGNMENT". AFTER THAT, IT HAD TO BE MANUALLY SELECTED EACH TIME WHICH OF THE ELECTRODE TYPES WAS INVOLVED. THE ELECTRODES WERE CORRECTLY CONNECTED TO THE DEVICE WHEN IT WAS SWITCHED ON. THE COLLEAGUES DISCONNECTED AND RECONNECTED THE ELECTRODES ONCE DURING THE ONGOING OPERATION. BUT WITHOUT SUCCESS. THE DEFIBRILLATOR DELIVERED THE REQUIRED SHOCK FOR EACH DEFIBRILLATION. THE CONNECTION WAS BROKEN EVEN INDEPENDENTLY OF A DEFIBRILLATION, SO THAT A LEAD WAS NOT AVAILABLE AT ALL TIMES. THE ELECTRODES USED CAN NO LONGER BE FOUND, SO THAT THE LOT NUMBER OF THE CONCERNED ELECTRODES CAN NO LONGER BE DETERMINED. THE LOT NUMBER OF THE ELECTRODES THAT ARE IN STORAGE AT THE RESCUE STATION: LOT 220216- 4012 EXPIRATION 2025-02-16; LOT 210602-4015 EXPIRY 2024-06-02; LOT 211129-4019 EXPIRES 2024-11-29. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910782 GS MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 210602-4015 19005531505302