MAUDE Adverse Event Report: Leonhard Lang GmbH Skintact; multifunction defibrillation electrode

Model Number	DF28N
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On august 20, 2026, we have been informed about a malfunction with a defibrillation electrodes at worcestershire acute hospitals nhs trust in the uk.Skintact defibrillation electrodes model df28n and an zoll defibrillator had been used.The initial report was stating that "following the receipt of the above fsn's we have been using the skintact defib electrodes, however, today we have identified that the pads aren't registering with the zoll defibs we use." it was also specified that customer samples will be available for further investigation.No further details have been disclosed.We will provide a follow up report once any further information will become available.
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 260319-5482 have been inspected visually and tested electrically for the function.All tested electrodes were within their electrical limits.Some retained samples of the lot number 260319-5482 did show the clomplained issues with the pluggability.We have received a total of (b)(4) unopened pouches from lot number 260319-5482 for further testing from the customer.To investigate the reported electrode failure that the electrodes were not recognized by the defibrillator the 100 customer electrodes were tested using a zoll x series defibrillator and a fluke impulse 7000dp defi analyzer.All (b)(4) customer samples established a stable electrical connection, achieved immediate device recognition, and correctly displayed the ecg signal (100% success rate).The reported failure could not be duplicated.However the testing showed that electrical continuity is established before full mechanical locking.The defibrillator recognizes the electrode and displays the ecg signal despite the locking tab does not engage and the audible "click" is absent, prior to reaching its final secured position.Additionaly a ventricular fibrillation was simulated using one customer sample and the fluke defi analyzer.The defibrillator correctly detected the arrhythmia, advised a shock, and successfully delivered the therapy.The technical evaluation established a direct correlation to the previous complaint (b)(4) and (b)(4).We will provide further information requestesd by the user and any conlcusion in a follow up report.

• 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: 50770682
• Report Number: 8020045-2026-00028
• Device Sequence Number: 18753402
• Product Code: MKJ
• UDI-Device Identifier: 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
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Expiration Date: 03/19/2026
• Device Model Number: DF28N
• Device Catalogue Number: MDF1C_SKIN DF28N ZOLL 1-10-60
• Device Lot Number: 260319-5482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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