MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; MULTIFUNCTION DEFIBRILLATION ELECTRODE

Model Number	DF28N
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is not marketed in the usa.However, a 510 (k) but no pma exist for it.We are therefore reporting the incident.Retained samples of the concerned lot number 260227-4044 and 260319-5482 have been inspected visually and tested electrically for the function.All tested electrodes were within their electrical limits.3 out of 4 of the retained samples (lot numbers 260227-4044 (2 retained samples) and 260319-5482 (2 retained samples)) did show the clomplained issues with the pluggability.The technical evaluation established a direct correlation to the previous complaint (b)(4); fda ref: (b)(4).Advanced imaging (x-ray and ct analysis) conducted at (b)(6) hospital (b)(6) identified an anomaly in the spring sleeve within the connector bushing.The cables and their connectors are tested on a sample basis during incoming inspection and undergo a 100% inspection for basic fit and electrical continuity during production.For lot approval finished electrode sets are tested for their electrical performance on a sample basis.While the final root cause investigation with the supplier is still ongoing, a reliable detection method to identify and sort out connectors showing the complained issue has been implemented and added as a 100% inspection.This was implemented in the production line of leonhard lang and will also be implemented in the production of the cable supplier.Testing performed on non-conforming connectors demonstrated that even if the clip fails to engage, the retention force within the zoll therapy cable connector exceeds the specified minimum requirement.Further information from the user site (b)(6), (previous complaint (b)(4) fda ref: (b)(4) stated [translated from german language to english language]: "the electrodes remain functional even if the locking mechanism is not fully engaged; the contact closes and enables normal operation (tested locally by our department management and subsequently continued)." we will inform all customers who have received the affected lot numbers with a field safety notice.No affected electrodes have been distributed to the usa and therefore no field corrective action or recall is required in the usa.We consider the investigation and the report closed for the usa.
Event or Problem Description
On (b)(6) 2026, we have been informed about a malfunction with a defibrillation electrode set at the customer st.George's hospital, cardiac catheter labs.Skintact defibrillation electrodes our model df28n and an unknown zoll defibrillator had been used.The initial report is stating that: " i am writing from (b)(6) hospital, cardiac catheter labs.We are regular users of the df28n defibrillation pads, and over the past few weeks we have encountered a significant number of faulty items across multiple lot numbers.The issue appears to be with the cable connection, which does not click into place securely.As a result, we are unable to use the affected pads, which is causing operational difficulties." later on, we have received a complaint form.Within this questionnaire it was stated that no "medical/surgical intervention required" and that "the device (s) changed out/replaced with no further problems encountered".It was also stated that two lot numbers are concerned: 260227-4044, 260319-5482.No further details have been disclosed.

• Brand Name: SKINTACT
• Common Device Name: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: thomas recheis ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 25729171
• Report Number: 8020045-2026-00020
• Device Sequence Number: 13382942
• Product Code: MKJ
• UDI-Device Identifier: 19005531501161
• UDI-Public: (01)19005531501161
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DF28N
• Device Catalogue Number: MDF1C_SKIN DF28N ZOLL 1-10-60
• Device Lot Number: 260227-4044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NONE
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown