BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS

    MDR report key: 14839638 · Received June 28, 2022

    Report

    Report Number
    8020045-2022-00019
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Report Date
    July 18, 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

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (220110-4011) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON JUNE 13TH, 2022 THE INVOLVED DEVICE WAS RECEIVED. IT WAS DISINFECTED AND THEN INSPECTED. A VISUAL INSPECTION OF THE DEFIBRILLATION SET SHOWED NO OBVIOUS DAMAGE. AT ONE DEFIBRILLATION ELECTRODE A DISCOLORATION OF THE TIN FOIL WAS VISIBLE. THE USED DEFIBRILLATION ELECTRODE WAS WITHOUT ABNORMALITIES. THE CONNECTOR 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 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). AS NO VISUAL AND NO ELECTRICAL CONTINUITY FAILURE COULD BE DETECTED AN ELECTRICAL PERFORMANCE TEST WAS CARRIED ON. FOR THIS TEST, GS PROVIDED A CURRENT CORPULS DEFIBRILLATOR. THE DEFIBRILLATOR ARRIVED AT LEONHARD LANG ON JUNE 22ND, 2022. THE INVOLVED ELECTRODE SETS WAS ADHERED ONTO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP AND CONNECTED TO THE GS CORPULS DEFIBRILLATOR. THE DEFIBRILLATOR WAS SWITCHED ON AND THE PADS WORKED PROPERLY - IMMEDIATELY AN ECG SIGNAL WAS VISIBLE ON THE DISPLAY. WE HAVE SIMULATED A VENTRICULAR FIBRILLATION AND HAVE SUCCESSFULLY SHOCKED TO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP. WE ALSO HAVE DONE A PACING. THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP HAS SHOWN THAT THE DEFIBRILLATION SET WORKED WITHOUT ANY DEVIATION. NEITHER VISUAL DAMAGES NOR DEVIATIONS AT THE CONNECTORS AS WELL AS NO ABNORMALITIES AT THE ELECTRODES ITSELF HAVE BEEN NOTICED FOR THE DEFIBRILLATION SET. THE CONTINUITY TEST WAS WITHIN LIMITS. A FUNCTIONALITY TEST WITH THE GS CORPULS DEFIBRILLATOR SHOWED THAT THE DEFIBRILLATION ELECTRODES INCLUDING THE INVOLVED DEVICE WORKED PROPERLY. THE NOTICED DISCOLORATION OF THE TIN FOIL ARE COSMETIC ISSUES AND DOES NOT HAVE ANY IMPACT TO THE ELECTRICAL PERFORMANCE OF THE ELECTRODE. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (220110-4011) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON JUNE 13TH, 2022 THE INVOLVED DEVICE WAS RECEIVED. IT WAS DISINFECTED AND THEN INSPECTED. A VISUAL INSPECTION OF THE DEFIBRILLATION SET SHOWED NO OBVIOUS DAMAGE. AT ONE DEFIBRILLATION ELECTRODE A DISCOLORATION OF THE TIN FOIL WAS VISIBLE. THE USED DEFIBRILLATION ELECTRODE WAS WITHOUT ABNORMALITIES. THE CONNECTOR 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 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). AS NO VISUAL AND NO ELECTRICAL CONTINUITY FAILURE COULD BE DETECTED AN ELECTRICAL PERFORMANCE TEST WAS CARRIED ON. FOR THIS TEST, GS PROVIDED A CURRENT CORPULS DEFIBRILLATOR. THE DEFIBRILLATOR ARRIVED AT (B)(4) ON JUNE 22ND, 2022. THE INVOLVED ELECTRODE SETS WAS ADHERED ONTO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP AND CONNECTED TO THE GS CORPULS DEFIBRILLATOR. THE DEFIBRILLATOR WAS SWITCHED ON AND THE PADS WORKED PROPERLY - IMMEDIATELY AN ECG SIGNAL WAS VISIBLE ON THE DISPLAY. WE HAVE SIMULATED A VENTRICULAR FIBRILLATION AND HAVE SUCCESSFULLY SHOCKED TO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP. WE ALSO HAVE DONE A PACING. THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP HAS SHOWN THAT THE DEFIBRILLATION SET WORKED WITHOUT ANY DEVIATION. NEITHER VISUAL DAMAGES NOR DEVIATIONS AT THE CONNECTORS AS WELL AS NO ABNORMALITIES AT THE ELECTRODES ITSELF HAVE BEEN NOTICED FOR THE DEFIBRILLATION SET. THE CONTINUITY TEST WAS WITHIN LIMITS. A FUNCTIONALITY TEST WITH THE GS CORPULS DEFIBRILLATOR SHOWED THAT THE DEFIBRILLATION ELECTRODES INCLUDING THE INVOLVED DEVICE WORKED PROPERLY. THE NOTICED DISCOLORATION OF THE TIN FOIL ARE COSMETIC ISSUES AND DOES NOT HAVE ANY IMPACT TO THE ELECTRICAL PERFORMANCE OF THE ELECTRODE. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE HAVE REQUESTED FURTHER INFORMATION CLARIFYING A POSSIBLE ROOT CAUSE AND HAVE BEEN INFORMED ON JULY 15TH, 2022 THAT: "I ASSUME THAT THE USER WILL NOT PASS ON ANY FURTHER INFORMATION ON THIS." WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER FACILITY IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT IS STATING THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: "THAT DURING A PACING MISSION, A LOOSE CONTACT OCCURRED BETWEEN THE EXTENSION CABLE AND THE [DEFIBRILLATION] ELECTRODE. AFTER EXAMINING THE DEVICE, A DEVICE DEFECT OR DEFECT IN THE EXTENSION CABLE CAN BE EXCLUDED. WE ARE ALREADY IN CONTACT WITH THE USER AND HAVE SENT HIM YOUR QUESTIONNAIRE FOR INCIDENTS. WE WILL SEND YOU THE USED CORPATCH EASY PRE-CONNECTED P/N 05120.1 WITH BATCH 220110-4011 FOR EXAMINATION." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR. WE HAVE REQUESTED FURTHER INFORMATION AND WE WILL FOLLOW UP ONCE WE HAVE RECEIVED THEM.

    Description of Event or Problem · 0

    ON JUNE 03RD, 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER FACILITY IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT IS STATING THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: "THAT DURING A PACING MISSION, A LOOSE CONTACT OCCURRED BETWEEN THE EXTENSION CABLE AND THE [DEFIBRILLATION] ELECTRODE. AFTER EXAMINING THE DEVICE, A DEVICE DEFECT OR DEFECT IN THE EXTENSION CABLE CAN BE EXCLUDED. WE ARE ALREADY IN CONTACT WITH THE USER AND HAVE SENT HIM YOUR QUESTIONNAIRE FOR INCIDENTS. WE WILL SEND YOU THE USED CORPATCH EASY PRE-CONNECTED P/N 05120.1 WITH BATCH 220110-4011 FOR EXAMINATION." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938028 GS MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 220110-4011 19005531505302

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other