BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINDRAY

    MDR report key: 15190010 · Received August 9, 2022

    Report

    Report Number
    8020045-2022-00026
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Report Date
    September 19, 2022
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531500294
    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. THE CONCERNED PRODUCT HAS NOT BEEN MADE AVAILEBLE TO US. WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE DEFIBRILLATION ELECTRODES IN POUCHES OF COMPARABLE DESIGN IN THE US. BASED ON THE CUSTOMER SAMPLE PICTURE, THE ASSEMBLY OR 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 AN INTERIM STORAGE FACILITY. AFTER SEALING THE POUCHES, EVERY POUCH IS THEN CHECKED IN A SEPERATE STEP IN THE ASSEMBLY LINE (ACCEPTANCE CRITERIA: NO POUCH MAY SHOW ANY DAMAGE OR POLLUTION). AFTER CHECKING, THE FINISHED SETS THEY ARE PLACED IN ZIP LOCK POUCHES AND PACKED AFTERWARD MANUALLY IN BOXES. WE HAVE REVIEWD THE ENTIRE ASSEMBLY AND TESTING EQUIPMENT IN THE CONCERNED PRODUCTION LINE. THERE ARE NO SPIKES OR SHARP EDGES REPSECTIVETLY SHARP OBJECTS (E.G. KNIVES) IN THE WHOLE ASSEMBLY OR PRODUCTION LINE USED THAT COULD CAUSE THE CLAIMED DEFECT. NO POSSIBLE CAUSE COULD BE IDENTIFIED WHICH COULD HAVE BEEN RESPONSIBLE FOR THE SCRATCH/TEAR IN THE POUCH MATERIAL (TRIPLEX FILM). HOWEVER WE HAVE REQUESTED THE CONCERNED PRODUCT FOR FURTHER INVESTIGATION. WE WILL RELAY ANY CONCLUSION IN A FOLLOW UP REPORT.

    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. THE CONCERNED PRODUCT HAS NOT BEEN MADE AVAILABLE TO US. WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE DEFIBRILLATION ELECTRODES IN POUCHES OF COMPARABLE DESIGN IN THE US. BASED ON THE CUSTOMER SAMPLE PICTURE, THE ASSEMBLY OR 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 AN INTERIM STORAGE FACILITY. 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 POLLUTION). 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. NO POSSIBLE CAUSE COULD BE IDENTIFIED WHICH COULD HAVE BEEN RESPONSIBLE FOR THE SCRATCH/TEAR IN THE POUCH MATERIAL (TRIPLEX FILM). WE HAVE REQUESTED THE CONCERNED PRODUCT FOR FURTHER INVESTIGATION AND FURTHER INFORMATION. THE INITIAL REPORTER HAS INFORMED US " WE BELIEVE THIS ISSUE IS CAUSED BY DELIVERY SERVICE PARTNER, SO PLEASE CLOSE THIS COMPLAINT AT YOUR SIDE." 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 MR60 (MODEL DF45C) AND AN UNKOWN MINDRAY AED DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT IS STATING THAT: "TODAY OUR IQC FOUND 9 OF YOUR ELECTRODE MR60 HAVE BELOW PACKING ISSUE" WE ALSO RECEIVED A PICTURE SHOWING THE CLAIMED DEFECT. REVIEWING THE CUSTOMER PICTURE SHOWING ONE POUCH WITH A SCRATCH IN THE FRONT SIDE OF THE POUCH. ACCORDING TO THE PICTURE IT IS NOT ENTERLY VISIBLE WHETHER TRACES ON THE POUCH CAN POINT TO A POSSIBLE ORIGIN OR CAUSE. IT IS ALSO UNCLEAR WHETHER THE TEAR WAS TORN INTO THE BAG FROM THE OUTSIDE IN OR FROM THE INSIDE OUT. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Description of Event or Problem · 0

    ON JULY 11TH, 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT THE CUSTOMER. MINDRAY DEFIBRILLATION ELECTRODES CATALOGUE NUMBER MR60 (MODEL DF45C) AND AN UNKOWN MINDRAY AED DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT IS STATING THAT: "TODAY OUR IQC FOUND 9 OF YOUR ELECTRODE MR60 HAVE BELOW PACKING ISSUE" WE ALSO RECEIVED A PICTURE SHOWING THE CLAIMED DEFECT. REVIEWING THE CUSTOMER PICTURE SHOWING ONE POUCH WITH A SCRATCH IN THE FRONT SIDE OF THE POUCH. ACCORDING TO THE PICTURE IT IS NOT ENTIRELY VISIBLE WHETHER TRACES ON THE POUCH CAN POINT TO A POSSIBLE ORIGIN OR CAUSE. IT IS ALSO UNCLEAR WHETHER THE TEAR WAS TORN INTO THE BAG FROM THE OUTSIDE IN OR FROM THE INSIDE OUT. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252862 MINDRAY MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF45C 220516-4306 19005531500294

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other