BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS CORPATCH

    MDR report key: 25077701 · Received May 5, 2026

    Report

    Report Number
    8020045-2026-00013
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Report Date
    May 27, 2026
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531002498
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXISTS FOR IT. HOWEVER, DEVICES MADE USING A SIMILAR DESIGN ARE SOLD IN THE US. WE ARE THEREFORE REPORTING THIS INCIDENT. RETAINED SAMPLES OF THE CONCERNED LOT NUMBER 250218-4897 HAVE BEEN INSPECTED VISUALLY, NO FAILURE COULD BE DETECTED. SINCE WE HAVE ALREADY RECEIVED A SIMILAR COMPLAINT FROM THE GERMAN AUTHORITY BFARM WITH THE SAME COMPLAINT REASON CONCERNING ALSO THE SAME AFFECTED LOT NUMBER, WE CONTACTED THE DISTRIBUTOR WHO INITIALLY REPORTED THE ISSUE TO INQUIRE FROM WHICH USER THE COMPLAINT IS ORIGINATED. WE INITIALLY SUSPECTED THAT IT IS THE SAME COMPLAINT, BUT RECEIVED FROM TWO DIFFERENT SOURCES. ON APRIL 27TH, 2026 WE HAVE BEEN INFORMED [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "AS IT STANDS, THIS IS A DIFFERENT CUSTOMER THAN THE ONE YOU MENTIONED. I THEREFORE ASK FOR YOUR PATIENCE UNTIL I HAVE FURTHER INFORMATION." WE HAVE REQUESTED THE AFFECTED SAMPLES FOR FURTHER INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED THE SAMPLES AND CONDUCTED ANY FURTHER INVESTIGATION .

    Description of Event or Problem · 0

    ON APRIL 08TH, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE 05120.5 CORPATCH EASY PRE-CONNEC (OUR MODEL DF53NC) HAVE BEEN USED. THE INITIAL REPORT DISCLOSED THE INFORMATION THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "WE RECEIVED A COMPLAINT ABOUT SWOLLEN ELECTRODE POUCHES." ON APRIL 29TH, 2026 WE HAVE RECEIVED ADDITIONAL INFORMATION THAT THE DISCREPANCY WAS DETECTED BY A POTENTIAL USER/EMERGENCY SERVICES. THE PRODUCT HAD BEEN STORED COOL, DRY, AND PROTECTED FROM LIGHT, JUST LIKE THE OTHER PACKAGES. WE ALSO HAVE REQUESTED IF THE PACKAGING HAVE BEEN STORED IN AN AMBULANCE CAR AND IT WAS DENIED "THE ELECTRODES WERE STILL IN THEIR PACKAGING". IT WAS ALSO STATED THAT "THE PACKAGING ON 2 OF THE 10 ORDERED ELECTRODE POUCHES IS BULGING" NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172290 GS CORPATCH MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 250218-4897 19005531002498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other