BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS CORPATCH

    MDR report key: 19404053 · Received May 28, 2024

    Report

    Report Number
    8020045-2024-00014
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 12, 2024
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531002481
    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 EXIST 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 230927-4899 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE HAVE REQUESTED FURTHER INFORMATION AND A FILLED IN QUESTIONNAIRE. WE WILL FOLLOW UP ONCE WE RECEIVE ANY.

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXIST 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 230927-4899 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE HAVE REQUESTED FURTHER INFORMATION AND A FILLED IN QUESTIONNAIRE AND HAVE BEEN INFORMED ON JUNE 11TH, 2024 THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "I LAST ASKED FOR THE INFORMATION I NEEDED ABOUT THIS PROCESS ON JUNE 4TH (4 TIMES IN TOTAL) AND HAVE NOT YET RECEIVED ANY RESPONSE. AS NO INVESTIGATION IS POSSIBLE BASED ON THE CURRENT INFORMATION, WE WILL CLOSE THE PROCESS FROM OUR SIDE". NO CONLCUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CUSTOMER PROBLEM. WE THEREFORE ALSO CLOSE THE INVESTIGATION AND THE REPORT.

    Description of Event or Problem · 0

    ON MAY 13TH, 2024, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER FACILITY IN FRANCE. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.4 CORPATCH EASY PRO (MODEL DF90NC) AND A GS CORPULS C3 DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE DEVICE DID NOT SHOCK, BUT ANOTHER AED SHOCKED THE PATIENT. ON READING THE MISSION, 11 ANALYZES WERE CARRIED OUT BUT NO ECG TRACINGS ARE AVAILABLE. ON THE MISSION WE CAN SEE THAT THE STATUS INDICATES THAT THE AED [DEFIBRILLATOR] NEEDS MAINTENANCE WITH AN ERROR ON THE DEFI MODULE. TODAY, THE DEVICE IS FUNCTIONAL AND SHOWS NO ERRORS WITH A NEW BATTERY (ACTUAL BATTERY'S CAPACITY VERY LOW). STATUS OF INVESTIGATION: THE ELECTRODES USED WERE DISPOSED OFF AFTER USE. AFTER REPLACING THE ELECTRODES, THE ERROR DISPLAYED DISAPPEARED AND COULD NO LONGER BE REPRODUCED. ITEM 05120.4 LOT 230927-4899. WE ASSUME THAT THE PATIENT WAS CONNECTED BEFORE THE CORPULS AED WAS SWITCHED ON. WE HAVE REQUESTED INFORMATION REGARDING A PATIENT INJURY AND THE PATIENT OUTCOME." ADDITIONALLY WE ALSO HAVE REQUESTED FURTHER INFORMATION AND THE USER TO FILL IN A QUESTIONNAIRE. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Description of Event or Problem · 0

    ON MAY 13TH, 2024, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER FACILITY IN FRANCE. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.4 CORPATCH EASY PRO (MODEL DF90NC) AND A GS CORPULS C3 DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE DEVICE DID NOT SHOCK, BUT ANOTHER AED SHOCKED THE PATIENT. ON READING THE MISSION, 11 ANALYZES WERE CARRIED OUT BUT NO ECG TRACINGS ARE AVAILABLE. ON THE MISSION WE CAN SEE THAT THE STATUS INDICATES THAT THE AED [DEFIBRILLATOR] NEEDS MAINTENANCE WITH AN ERROR ON THE DEFI MODULE. TODAY, THE DEVICE IS FUNCTIONAL AND SHOWS NO ERRORS WITH A NEW BATTERY (ACTUAL BATTERY'S CAPACITY VERY LOW). STATUS OF INVESTIGATION: THE ELECTRODES USED WERE DISPOSED OFF AFTER USE. AFTER REPLACING THE ELECTRODES, THE ERROR DISPLAYED DISAPPEARED AND COULD NO LONGER BE REPRODUCED. ITEM 05120.4 LOT 230927-4899 WE ASSUME THAT THE PATIENT WAS CONNECTED BEFORE THE CORPULS AED WAS SWITCHED ON. (...) WE HAVE REQUESTED INFORMATION REGARDING A PATIENT INJURY AND THE PATIENT OUTCOME." ADDITIONALLY WE ALSO HAVE REQUESTED FURTHER INFORMATION AND THE USER TO FILL IN A QUESTIONNAIRE. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676710 GS CORPATCH MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF90NC 230927-4899 19005531002481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other