BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS

    MDR report key: 17029170 · Received May 31, 2023

    Report

    Report Number
    8020045-2023-00015
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Report Date
    May 31, 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

    AS NEITHER A LOT NUMBER NOR SAMPLES HAVE BEEN MADE AVAILABLE TO US, NO ANALYSES COULD BE PERFORMED SO FAR. NO INVESTIGATION COULD BE CARRIED OUT BASED ON THE INFORMATION PROVIDED. IN ANY CASE, THE COMPLAINANT CLAIMS THE COVER LINER OF AN ELECTRODE PAD COULD NOT BE REMOVED BECAUSE IT WAS ATTACHED WITH THE NON-SILICONIZED SIDE TOUCHING THE GEL. DURING THE PRODUCTION PROCESS A SILICONIZED LINER IS LAMINATED TO THE PAD LINER. THE ELECTRODES ARE CUT FROM THE LAMINATED LINER LATER IN THE PROCESS. THE PROTECTIVE COVER LINER IS NEVER LIFTED OFF THE PRODUCT DURING PRODUCTION, ASSEMBLY OR PACKAGING. IF AN ENTIRE ROLL OF PROTECTIVE LINER MATERIAL HAD BEEN INTRODUCED INTO THE MACHINE THE WRONG WAY (SILICONIZED SIDE FACING THE GEL) AN ENTIRE LOT OF ELECTRODES WOULD HAVE BEEN AFFECTED. SUCH A CONDITION WOULD HAVE BEEN DETECTED DURING LOT APPROVAL INSPECTIONS OR EVEN DURING THE PRODUCTION OR ASSEMBLY PROCESS. HOWEVER, AS NO LOT NUMBER HAS BEEN DISCLOSED FOR THE INVOLVED PRODUCT WE CANNOT CHECK FOR THIS WITH OUR RESPECTIVE PRODUCTION REPORTS. NO OTHER COMPLAINTS OF THAT NATURE HAVE BEEN FILED FOR THIS PRODUCT. IT IS THEREFORE MOST LIKELY THAT THE USER HAVE REMOVED THE PROTECTIVE COVER OF A PAD AT SOME STAGE IN THEIR PROCEDURE AND REATTACHED IT WITH THE WRONG SIDE UP. WE ASSUME THAT THE CONCERNED DEFIBRILLATION SET MET THE SPECIFIED PARAMETERS AT THE TIME OF APPROVAL AND THAT THE DEFECT OR INCIDENT COMPLAINED ABOUT WAS NOT CAUSED BY LEONHARD LANG GMBH. THE INITIAL REPORT WAS ALSO SPECIFYING THAT "WE WILL CLOSE THIS CASE IN OUR SYSTEM". NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE THEREFORE CLOSE ALSO THE INVESTIGATION. 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.

    Description of Event or Problem · 0

    ON MAY 16TH, 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER IN THE NETHERLANDS. 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 "WE'VE REGISTERED A VIGILANCE NOTIFICATION OF OUR CUSTOMER WITH REGARDS TO ARTICLE 05120.1. PROTECTIVE FOIL WAS INCORRECTLY APPLIED TO THE ELECTRODE. PERSONNEL WAS UNABLE TO REMOVE THE FOIL FROM THE ELECTRODE DURING CPR MISSION. LUCKILY THIS HAD NO IMPACT FOR THE PATIENT. BUT OFC. THIS COULD'VE HAD IMPACT. FOR THIS REASON WE PUSH THE NOTIFICATION FORWARD. WE HAVE NO LOT NO. AVAILABLE SADLY. WE BELIEVE THIS IS AN INCIDENT AS WE DIDN'T RECEIVE MORE FEEDBACK FROM THE FIELD WITH REGARDS TO THIS ISSUE." FURTHER ON THE INITIAL REPORTER STATED THAT WHETHER THE AFFECTED ELECTRODE, THE LOT NUMBER NOR PHOTOS OF THE MALFUNCTION ARE AVAILABLE NO FURTHER INVESTIGATION IS POSSIBLE. IT WAS ALSO REPORTED THAT NO PATIENT INJURY HAS BEEN REPORTED TO US. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160536 GS MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF53NC 19005531505302

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other