BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS

    MDR report key: 18189504 · Received November 22, 2023

    Report

    Report Number
    8020045-2023-00026
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Report Date
    February 7, 2023
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531505302
    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 230612-4893 HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON (B)(6) 2023 THE ELECTRODE SET INVOLVED IN THE INCIDENT WAS RETURNED IN AN OPEN PE POUCH, ELECTRODES STUCK GEL TO GEL TOGETHER. THE ELECTRODE SET INVOLVED IN THE INCIDENT WAS DISINFECTED AND THEN INSPECTED. ADDITIONAL WE ALSO HAVE RECEIVED A CUSTOMER SAMPLE FROM THE CONCERNED LOT NUMBER IN ITS ORIGINAL UNOPENED PACKAGING. INSPECTING THE INVOLVED ELECTRODES WE DETECTED THAT THE GEL SURFACE OF BOTH ELECTRODES HAD BEEN POLLUTED WITH SKIN PARTICLES AND PATIENT HAIR. THE GEL HAD DRIED SEVERELY DUE TO BEING PROVIDED IN AN OPEN PE POUCH AND SHOWED TRACES OF CRYSTALLIZATION. IT WAS IN A STATE NOT SUITABLE FOR AN ADHESION TEST. THE CONCERNED DEFIBRILLATION ELECTRODE SET SHOWED NO OTHER OBVIOUS DAMAGE. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED USING A MULTIMETER. THE SAMPLE WAS WITHIN LIMITS. THE ADDITIONAL RETURNED DEFIBRILLATION ELECTRODE SET FROM THE CONCERNED LOT NUMBER WAS INSPECTED VISUAL. AN ADHESION TEST WAS PERFORMED ON THE RETURNED DEFIBRILLATION ELECTRODES FROM THE CONCERNED LOT NUMBER, WHICH WERE PROVIDED IN THEIR ORIGINAL UNOPENED PACKAGING. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. WE HAVE REQUESTED SEVERAL TIMES FOR FURTHER INFORMATION AND A FILLED IN QUESTIONAIRE AND HAVE BEEN INFORMD ON FEBRUARY 06TH, 2024 THAT "NO FURTHER INFORMATION IS AVAILABLE". NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    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 230612-4893 HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US. WE HAVE REQUESTED THE CONCERNED CUSTOMER SAMPLE AND A FILLED IN QUESTIONAIRE. WE WILL FURTHER INVESTIGATE AND PROVIDE A FOLLOW-UP REPORT ONCE RECEIVED.

    Description of Event or Problem · 0

    ON OCTOBER 23RD, 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKOWN LOCATION. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECT (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE USER REPORTED LAST WEEK THAT THEY USED TWO OF THESE PADS LAST WEEK DURING A MISSION. NEITHER OF THE PADS STUCK PROPERLY TO THE PATIENT. AMBULANCE PERSONNEL HELD DOWN THE PADS TO DO AN ANALYSIS BECAUSE THEY FELL OFF IF THEY HADN'T. THE AMBULANCE PERSONNEL COMPARED THE PADS TO THE ONES USED ON LP15 AND CLAIM THEY ARE LESS ADHESIVE THAN THE LP15 ONES. THAT MIGHT BE THE CASE, BUT THESE DIDN'T WORK AT ALL. WE HAVE ASKED ABOUT THE HYGIENE OF THE PATIENT IF THERE WAS ANY THING THAT STOOD OUT, BUT THE PATIENT DIDN'T SEEM TO HAVE BAD HYGIENE/CREAM. THE PATIENT WAS WARM, DRY AND NOT SWEATY OR CLAMMY." REQUESTING FURTHER INFORMATION WE HAVE BEEN INFORMED THAT "NO HARM TO THE PATIENT DURING USE. FUNCTIONING ELECTRODES WOULD NOT CHANGE PATIENTS OUTCOME." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR. WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT, THE MONITORING DURATION AND THE MEDICAL TREATMENT.

    Description of Event or Problem · 0

    ON OCTOBER 23RD, 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN LOCATION. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECT (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE USER REPORTED LAST WEEK THAT THEY USED TWO OF THESE PADS LAST WEEK DURING A MISSION. NEITHER OF THE PADS STUCK PROPERLY TO THE PATIENT. AMBULANCE PERSONNEL HELD DOWN THE PADS TO DO AN ANALYSIS BECAUSE THEY FELL OFF IF THEY HADN'T. THE AMBULANCE PERSONNEL COMPARED THE PADS TO THE ONES USED ON LP15 AND CLAIM THEY ARE LESS ADHESIVE THAN THE LP15 ONES. THAT MIGHT BE THE CASE, BUT THESE DIDN'T WORK AT ALL. WE HAVE ASKED ABOUT THE HYGIENE OF THE PATIENT IF THERE WAS ANY THING THAT STOOD OUT, BUT THE PATIENT DIDN'T SEEM TO HAVE BAD HYGIENE/CREAM. THE PATIENT WAS WARM, DRY AND NOT SWEATY OR CLAMMY." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR. WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT, IF THE PATIENT WAS INJURED AND WHETHER THE PATIENT HAS TO BE TREATED, THE MONITORING DURATION AND THE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722370 GS MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 230612-4893 19005531505302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other