BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS

    MDR report key: 15864031 · Received November 25, 2022

    Report

    Report Number
    8020045-2022-00030
    Event Type
    Malfunction
    Date Received
    November 25, 2022
    Date of Event
    October 31, 2022
    Report Date
    March 9, 2023
    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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBERS 220110-4011, 210607-4016, 220214-4011 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON DECEMBER 07TH, 2022 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 OF THE INVOLVED ELECTRODE SET WAS ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. 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 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. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED USING A MULTIMETER TO TEST FOR ELECTRICAL CONTINUITY. INITIALLY THE PINS OF THE CONNECTOR WERE TOUCHED BUT NO PRESSURE WAS EXERTED. BOTH LEADS AS WELL AS THE CODING RESISTOR IN THE CONNECTOR HAD CONTINUITY. PRESSURE WAS THEN APPLIED TO THE MEASURING TIPS DURING MEASUREMENT ON THE CONTACTED CONNECTOR. THESE TESTS REVEALED THAT THE CODING RESISTOR'S VALUE CHANGED AND DID NOT REMAIN CONSTANT. THE ROOT CAUSE WAS IDENTIFIED TO BE THE METHOD (CRIMPING) THE RESISTOR WAS CONNECTED WITH TO THE RESPECTIVE CONTACT PINS. AS A CORRECTIVE ACTION THE RESISTOR IS CONNECTED TO THE CONTACT PINS WITH A SOLDERING PROCESS. THE REPORTED ISSUE AFFECTS A LOT WHICH WAS PRODUCED BEFORE THE CORRECTIVE ACTION WAS TAKEN. FURTHERMORE, THE RISK WAS RE-EXAMINED BY THE COMPANY GS BASED ON THE CURRENT NUMBER OF COMPLAINTS. THE FOLLOWING CONCLUSION WAS FINALLY MADE BY GS AND RECEIVED BY US ON FEBRUARY 15TH, 2023: "DUE TO THE FACT, THAT THIS IS A COMBINED RESPONSE, NO DETAILED ANALYSE OF THE HAZARDOUS SITUATION IS POSSIBLE. IT IS ASSUMED, THAT THERE WAS A CERTAIN DELAY IN THE TREATMENT, WHEN IT OCCURRED DURING A RESUSCITATION." BASED ON THE RISK ASSESMENT OF COMPANY GS NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBERS 220110-4011, 210607-4016, 220214-4011 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. CURRENTLY NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE WILL FURTHER INVESTIGATE AND RELAY THE CONCLUSION IN A FOLLOW UP REPORT. ANYHOW WE WILL CONTINUE TO REQUEST FOR FURTHER INFORMATION AND PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED.

    Description of Event or Problem · 0

    ON NOVEMBER 04TH, 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT EMERGENCY MEDICAL SERVICE OF THE CITY OF PRAGUE IN CZEH REPUBLIC. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS C3 DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT STATED "WE WOULD LIKE TO INFORM YOU THAT A CUSTOMER HAS REPORTED FAILURES WITH CORPATCH EASY ELECTRODE 05120.1 WITH THE FOLLOWING BATCHES. 220110-4011; 210607-4016; 220214-4011. FAILED ELECTRODES WITH THE ABOVE BATCHES ARE SENT TO US, WE WILL IMMEDIATELY FORWARD THEM TO YOU FOR ANALYSIS." WE HAVE REQUESTED FURTHER INFORMATION AND HAVE RECEIVED TWO PARTIALLY FILLED IN QUESTIONAIRES RELATING TO TWO INCIDENTS. FOR THE FIRST INCIDENT HAPPEND ON (B)(6) IT WAS STATED THAT: "ELECTRODES CAN`T BE CONNECTED TO A DEFIBRILLATOR - WHEN TRYING TO CONNECT THE ELECTRODES, DEFIBRILLATOR KEEP SAYING TO CONNECT THE ELECTRODES EVEN THOUGH THE ELECTRODES ARE PHYSICALLY CONNECTED. IF WE TRY ANOTHER ELECTRODES OF SAME TYPE, THEN IT WORKS." CONCERNED AND AFFECTED LOT NUMBER 220110-4011. FOR THE SECOND INCIDENT HAPPEND ON NOVEMBER 11TH IT WAS STATED THAT: "ELECTRODES CAN`T BE CONNECTED TO A DEFIBRILLATOR - WHEN TRYING TO CONNECT THE ELECTRODES, DEFIBRILLATOR KEEP SAYING TO CONNECT THE ELECTRODES EVEN THOUGH THE ELECTRODES ARE PHYSICALLY CONNECTED." CONCERNED AND AFFECTED LOT NUMBER 220214-4011. FOR BOTH INCIDENTS IT WAS SPECYFIED THAT "NO, THE PATIENTS WERE NOT HARMED." NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Description of Event or Problem · 0

    ON NOVEMBER 04TH, 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) IN CZEH REPUBLIC. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS C3 DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT STATED "WE WOULD LIKE TO INFORM YOU THAT A CUSTOMER HAS REPORTED FAILURES WITH CORPATCH EASY ELECTRODE 05120.1 WITH THE FOLLOWING BATCHES. 220110-4011, 210607-4016, 220214-4011. FAILED ELECTRODES WITH THE ABOVE BATCHES ARE SENT TO US, WE WILL IMMEDIATELY FORWARD THEM TO YOU FOR ANALYSIS" WE HAVE REQUESTED FURTHER INFORMATION AND HAVE RECEIVED TWO PARTIALLY FILLED IN QUESTIONAIRES RELATING TO TWO INCIDENTS. FOR THE FIRST INCIDENT HAPPENED ON (B)(6) 2022 IT WAS STATED THAT: "ELECTRODES CAN`T BE CONNECTED TO A DEFIBRILLATOR - WHEN TRYING TO CONNECT THE ELECTRODES, DEFIBRILLATOR KEEP SAYING TO CONNECT THE ELECTRODES EVEN THOUGH THE ELECTRODES ARE PHYSICALLY CONNECTED. IF WE TRY ANOTHER ELECTRODES OF SAME TYPE, THEN IT WORKS." CONCERNED AND AFFECTED LOT NUMBER 220110-4011. FOR THE SECOND INCIDENT HAPPENED ON (B)(6) 2022 IT WAS STATED THAT: "ELECTRODES CAN`T BE CONNECTED TO A DEFIBRILLATOR - WHEN TRYING TO CONNECT THE ELECTRODES, DEFIBRILLATOR KEEP SAYING TO CONNECT THE ELECTRODES EVEN THOUGH THE ELECTRODES ARE PHYSICALLY CONNECTED." CONCERNED AND AFFECTED LOT NUMBER 220214-4011. FOR BOTH INCIDENTS IT WAS SPECIFIED THAT "NO, THE PATIENTS WERE NOT HARMED." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759438 GS MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 220110-4011 19005531505302

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other