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	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On august 25th, 2026, we have been informed about a malfunction with a defibrillation electrode set at (b)(6) hospital in the uk.Skintact defibrillation electrodes model df28n and a zoll defibrillator had been used.The initial mhra report (mhra reference number: (b)(4)) was stating that "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.Defib pad connector cannot be pushed into the zoll defib trunk cable.Loose electrical connection, at risk of disconnecting when in use.As a result, we are unable to use the affected pads, which is causing operational difficulties." on this form it was also stated that "all affected stock has been removed from the stockroom, discarded, and segregated from usable inventory.Using an alternative electrode from another supplier." no further details have been disclosed despite repeated requests.
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.We have received the same complaint by the user (b)(6) hospital via the fannin complaint under the fannin ref.: (b)(4)- df28n - (b)(6); our ref.: (b)(4); fda ref: 8020045-2026-00020.Specifically, the complaint was initially reported to us, which subsequently triggered the fsn, and this feedback regarding the same defect was then re-routed back to us via the mhra, containing the exact same issue.Within the field safety notice (fsn) it was stated that no further measures or actions are necessary.It was also specified that the field safety notice (fsn) for the user and does not constitute a recall.Consequently, no products need to be removed from the market or replaced.Fannin has requested further information at the user site (b)(6) hospital.We have not received feedback from the customer.We will provide further information requested by the user and any conclusion 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: 50911351
• Report Number: 8020045-2026-00029
• Device Sequence Number: 5330295
• 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
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/28/2026
• 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