BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS CORPATCH

    MDR report key: 24602781 · Received March 16, 2026

    Report

    Report Number
    8020045-2026-00008
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 7, 2026
    Report Date
    April 9, 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. BASED ON THE GERMAN AUTHORITY REPORT FORM THE E-MAIL CONTACT ADRESS WAS MENTIONED FROM THE INITIAL REPORTER AT THE USER SITE. WE HAVE REQUESTED THE CONCERNED CUSTOMER SAMPLES FOR FURTHER INVESTIGATION AND ADDITIONALLY INFORMATION AT THE USER SITE REPEATEDLY AND HAVE RECEIVED NO FURTHER INFORMATION FROM THE INITIAL REPORTER. WE ARE UNSURE WHETHER A REPORTABLE EVENT RESPECTIVELY A PRODUCT MALFUNCTION HAS OCCURRED AT ALL. HOWEVER BASED ON THE PROVIDED INFORMATION IT WAS NOT POSSIBLE TO DETERMINE. DESPITE REPEATED REQUESTS NO FURTHER INFORMATION RESPECTIVELY THE CONCERNED SAMPLE WAS AVAILABLE. THEREFORE NO ROOT CAUSE COULD BE DETERMINED. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT TO BE CLOSED.

    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. WE HAVE REQUESTED THE CONCERNED CUSTOMER SAMPLES FOR FURTHER INVESTIGATION. WE ARE CURRENTLY UNSURE WHETHER A REPORTABLE EVENT RESPECTIVELY A PRODUCT MALFUNCTION HAS OCCURRED AT ALL. HOWEVER, WE WILL PROVIDE FURTHER INFORMATION, INVESTIGATION RESULTS AND ANY CONCLUSION IN A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    ON FEBRUARY 12TH, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE 05120.5 CORPATCH EASY PRE-CONNEC (OUR MODEL DF53NC) HAVE BEEN CONCERNED. THE INITIAL REPORT DISCLOSED THE INFORMATION THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "THE ELECTRODE PACKING IS SWOLLEN." NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUESTS.

    Description of Event or Problem · 0

    ON (B)(6) 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT(B)(6) HOSPITAL IN (B)(6). GS DEFIBRILLATION ELECTRODES CATALOGUE 05120.5 CORPATCH EASY PRE-CONNECT (OUR MODEL DF53NC) HAVE BEEN CONCERNED. THE INITIAL REPORT DISCLOSED THE INFORMATION THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "THE ELECTRODE PACKING IS SWOLLEN." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665435 GS CORPATCH MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 250218-4897 19005531002498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other