BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINDRAY

    MDR report key: 17285892 · Received July 10, 2023

    Report

    Report Number
    8020045-2023-00020
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Report Date
    July 10, 2023
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531500291
    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 (220516-4306) HAVE BEEN INSPECTED VISUALLY. ALL SAMPLES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE DEFIBRILLATION ELECTRODES IN POUCHES OF COMPARABLE DESIGN IN THE US. ON JULY 03RD WE RECEIVED THE CLAIMED CUSTOMER SAMPLES FOR INVESTIGATION. AS THE FIRST CUSTOMER SAMPLE SHOWED A TEAR IN THE BACK SIDE OF THE POUCH, THE ASSEMBLY AND TESTING EQUIPMENT IN THE CONCERNED PRODUCTION LINE WAS EXAMINED. THE FULLY ASSEMBLED ELECTRODE SET IS PLACED IN THE POUCH MANUALLY. THE ELECTRODE POUCHES THAT ARE STILL OPEN ARE THEN PLACED IN A SHORT TERM BUFFER CONTAINER. AFTER SEALING THE POUCHES, EVERY POUCH IS THEN CHECKED IN A SEPARATE STEP IN THE ASSEMBLY LINE (ACCEPTANCE CRITERIA: NO POUCH MAY SHOW ANY DAMAGE OR CONTAMINATION). AFTER CHECKING, THE FINISHED SETS THEY ARE PLACED IN ZIP LOCK POUCHES AND PACKED AFTERWARD MANUALLY IN BOXES. WE HAVE REVIEWED THE ENTIRE ASSEMBLY AND TESTING EQUIPMENT IN THE CONCERNED PRODUCTION LINE. THERE ARE NO SPIKES OR SHARP EDGES RESPECTIVELY SHARP OBJECTS (E.G. KNIVES) IN THE WHOLE ASSEMBLY OR PRODUCTION LINE USED THAT COULD CAUSE THE CLAIMED DEFECT OF THE POUCH IN THE FRONT SIDE. NO POSSIBLE CAUSE COULD BE IDENTIFIED WHICH COULD HAVE BEEN RESPONSIBLE FOR THE SCRATCH/TEAR IN THE POUCH FRONT SIDE MATERIAL (TRIPLEX FILM). THE SECOND CLAIMED POUCH WITH A DEFECT ON THE FRONT SIDE NEAR THE GROMMET SEALING WAS TESTED FOR TIGHTNESS. NO LEAK WAS DISCOVERED. THE CLAIMED DEFECT THEREFORE IS A VISUAL DEFECT WITH NO INFLUENCE ON THE PRODUCT QUALITY. NO FURTHER CONCLUSION CAN BE DRAWN. WE THEREFORE CLOSE THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6), 2022, WE HAVE BEEN INFORMED BY OUR CUSTOMER MINDRAY ABOUT A FAILURE WITH DEFIBRILLATION ELECTRODE SETS. MINDRAY DEFIBRILLATION ELECTRODES CATALOGUE NUMBER MR60 (MODEL DF45C) HAD BEEN DETECTED AS DEFECTIVE DURING FURTHER PROCESSSING OF THE DEFIBRILLATION ELECTRODES IN THE MANUFACTURING LINE AT MINDRAY. THE INITIAL REPORT IS STATING THAT: "THERE ARE 2PCS MR60 PACKAGE DAMAGED". WE ALSO RECEIVED TWO PICTURES SHOWING THE CLAIMED DEFECT. REVIEWING THE CUSTOMER PICTURE SHOWING ONE POUCH WITH A DEFECT IN THE FRONT SIDE OF A POUCH NEAR THE GROMMET SEALING. ACCORDING TO THE PICTURE IT IS NOT ENTERLY VISIBLE WHETHER TRACES ON THE POUCH CAN POINT TO A POSSIBLE ORIGIN OR CAUSE. THE SECOND PICTURE IS SHOWING A TEAR IN THE BACK SIDE OF A POUCH. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571687 MINDRAY MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF45C 230403-4306 19005531500291

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other