BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINDRAY

    MDR report key: 15162013 · Received August 4, 2022

    Report

    Report Number
    8020045-2022-00025
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Report Date
    August 4, 2022
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531001760
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (211019-4014) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON JULY 12TH, 2022 THE INVOLVED DEVICE WAS RECEIVED. A VISUAL INSPECTION OF THE DEFIBRILLATION SET SHOWED NO OBVIOUS DAMAGE. THE CONNECTOR OF THE INVOLVED ELECTRODE SET WAS ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. THE SAMPLE INVOLVED WAS CHECKED FOR PLUGGABILITY ON THE MINDRAY DEFIBRILLATOR. IT WAS NOT POSSIBLE TO PLUG IN THE CONCERNED DEFIBRILLATION SET AT THE MINDRAY DEFIBRILLATOR. UPON CLOSER EXAMINATION OF THE CONNECTOR'S PINS, ONE OF THE OUTER PINS APPEARED TO HAVE A SPRING BUSH AROUND IT, WHICH PREVENTED IT FROM BEING PLUGGED IN. ALL CONNECTOR TESTING EQUIPMENT USED IN PRODUCTION WERE EXAMINED. THE RETURNED SAMPLE COULD NOT BE FULLY INSERTED INTO ANY OF THE CONNECTOR TESTING EQUIPMENT USED FOR PRODUCING THE CONCERNED DEFIBRILLATION ELECTRODE MODEL. DURING A DESTRUCTIVE TEST OF THE CONNECTOR OF THE INVOLVED DEVICE, THE PLASTIC PART AROUND THE PIN WAS REMOVED AND THE PIN WAS EXPOSED, IT WAS VERIFIED THAT THERE WAS A SPRING BUSH AROUND ON THE PIN. THE SPRING BUSH COULD BE MOVED ON THE PIN, ITS SEAT WAS LIGHT. THE GOLD-PLATED SPRING BUSH IS 6MM LONG AND TAPERING IN DIAMETER FROM 2.35MM - 1.6MM - 2.35MM IN SIZE. AFTER REMOVING THE SPRING BUSH FROM THE PIN, THE CONNECTOR COULD BE PLUGGED INTO ALL TEST EQUIPMENT AND THE PROGRAMMING OF THE RETURNED SAMPLE WAS READ OUT. THE PROGRAMMING WAS FAULTLESS AND THE DISPLAY SHOWED: "PADS STATUS: ADULTS PADS. NORMAL. EXPIRES 2026/10." THE FACT THAT THE CONNECTOR WAS FULLY PROGRAMMED SHOWS THAT THE CONNECTOR WAS WITHOUT ANY OBSTRUCTING ELEMENT (THE SPRING BUSH) AT THE TIME OF ITS ASSEMBLY AND TESTING. IT WAS THEN CHECKED, WHETHER A SPRING BUSH AS FOUND ON THE PIN WAS USED ON ANY ASSEMBLY OR TESTING EQUIPMENT IN THE CONCERNED PRODUCTION LINE. IT WAS FOUND THAT NO SUCH SPRING BUSH IS USED OR PROCESSED IN THE ENTIRE DEFIBRILLATION ELECTRODE PRODUCTION AREA OF LEONHARD LANG. IT WAS THEREFORE PROVEN THAT THE SPRING BUSH WAS NOT INTRODUCED DURING MANUFACTURING OPR TESTING AT LEONHARD LANG. THE PRODUCT IS A PRE-CONNECT MODEL, WHICH MEANS ITS CONNECTOR IS LED OUT OF THE SEALED POUCH AND THEREFORE COULD BE ACCESSED BY ANYONE OPENING THE PROTECTIVE PLASTIC ZIP-LOCK BAG. IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE SPRING BUSH WAS ADDED BY TAMPERING DURING TRANSPORT OR BY ACTIONS OF THE DISTRIBUTOR OR A USER. WE THEREFORE CLOSE THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT THE CUSTOMER. MINDRAY DEFIBRILLATION ELECTRODES CATALOGUE NUMBER MR62 5Y (MODEL DF45C) AND A UNKNOWN MINDRAY AED DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT IS STATING THAT: "THERE IS SOMETHING WRONG WITH THE PIN AND IT CANNOT BE INSERTED INTO OUR AED NO MATTER HOW HARD WE TRY." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380865 MINDRAY MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF81CZ 211019-4014 19005531001760

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other