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

Model Number DF27N

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Retained samples of the concerned lot number 220607-4045 have been inspected visually and tested electrically for the function.All tested electrodes were within limits, no failure could be detected.Currently we are awaiting the concerned customer samples for further investigation.So far, no conclusion can be drawn what might have caused the claimed problem.We will provide a follow-up report.

Event Description

On (b)(6) 2023, we have been informed about a malfunction with a defibrillation electrode set at an unknown user site in (b)(6).Skintest defibrillation electrodes model df27n and a phillips heartstart fr x had been used.The complainant reported "there are 2 phillips heartstart fr x machines.Df27n works fine on 1 machine, but on the second machine the message: not ready, appears on the other one." we have requested further information and the concerned defibrillation set for further investigation.

Event Description

On (b)(6) 2023, we have been informed about a malfunction with a defibrillation electrode set at an unknown user site in johannesburg, south africa.Skintact defibrillation electrodes model df27n and a phillips heartstart fr x had been used.The complainant reported "there are 2 phillips heartstart fr x machines.Df27n works fine on 1 machine, but on the second machine the message: not ready, appears on the other one." we have requested further information and the concerned defibrillation set for further investigation.

Manufacturer Narrative

Retained samples of the concerned lot number 220607-4045 have been inspected visually and tested electrically for the function.All tested electrodes were within limits, no failure could be detected.On (b)(6) 2023 our customer has confirmed that the concerned sample is not available for further investigation and that it has been disposed of.As neither the involved device nor samples of the same lot number from the user have been made available no root cause can be detected and therefore no conclusion can be drawn what might have cause the claimed failure.We therefore consider the investigation and the report closed.

• Brand Name: SKINTACT
• Type of Device: 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: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 17422868
• MDR Text Key: 320017653
• Report Number: 8020045-2023-00022
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 19005531506385
• UDI-Public: (01)19005531506385
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K142803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

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
• Device Operator: Health Professional
• Device Model Number: DF27N
• Device Lot Number: 220607-4045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other