BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS

    MDR report key: 16012979 · Received December 20, 2022

    Report

    Report Number
    8020045-2022-00032
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 11, 2022
    Report Date
    December 20, 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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (211108-3996) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON (B)(6) 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. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2022 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT A VOLUNTEER FIRE RESCUE SERVICE NITTENAU IN (B)(6). GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "OUR CUSTOMER REPORTED A DEFECT IN A 05120.1BA CORPATCH EASY PRE-CONNECTED ELECTRODE WITH BATCH 210929-4016. THIS FAILED DURING THE DAILY DEVICE TEST AND THERE WAS NO PATIENT HARM." FURTHER ON WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONAIRE REPORTING A PAIR OF ELECTRODES AS DEFECTIVE: "WHEN SWITCHED ON, THE DEVICE ONLY SPORADICALLY RECOGNIZES THE ELECTRODES, WHICH IS WHY WE HAD TO REPLACE THEM". WE HAVE REQUESTED FURTHER INFORMATION ON THE MALFUNCTION AND THE CONCERNED SAMPLES FOR INVESTIGATION. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908370 GS MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 210929-4016 19005531505302

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other