MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; DF20NC

Model Number	SKINTACT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The retained samples of the same lot have been inspected visually and tested electrically.Mechanical tests were performed on 2 retained samples.All samples were found to perform within limits.No faults could be detected.The customer announced that we will receive samples for further investigation.Due to the lack of information, we were unable to establish, whether this malfunction constitutes a reportable incident.We have requested additional information several times but have not received any yet and have thus not been able to reach any further conclusions.When we will receive this information we will provide an update in a follow-up report.Not returned.
Event or Problem Description
On (b)(6) 2017, we have been informed by (b)(4), about a potential malfunction of a defibrillation electrode df20 nc and a lifepack 20 defibrillator at (b)(6).The complainant reported he was informed by the hospital about an incident involving df20 nc, lot 170406-0979.A physician wanted to perform a cardioversion on a patient of more than (b)(6) of weight.Two attempts failed.They replaced the electrode with a quickcombo electrode from medtronic.They were able to perform the procedure then.The delay caused by the malfunction caused no harm to the patient.A sample of the same lot as the electrode involved in the incident is being sent to us.No further information had been made available to us despite repeated requests.It was stated: "i will not receive any other answer from the customer before (b)(6).He left for holidays.".
Additional Manufacturer Narrative
The retained samples of the same lot have been inspected visually and tested electrically.Mechanical tests were performed on 2 retained samples.All samples were found to perform within limits.No faults could be detected.The customer announced that we will receive samples for further investigation.Due to the lack of information, we were unable to establish, whether this malfunction constitutes a reportable incident.We have requested additional information several times and were informed by our distributor on (b)(6): "unfortunately the person does not remember and is not able to give an answer.Please consider this file as closed." we therefore consider the investigation closed and no further conclusion can be drawn.
Event or Problem Description
On (b)(6) 2017, we have been informed by (b)(6), about a potential malfunction of a defibrillation electrode df20 nc and a lifepack 20 defibrillator at (b)(6).The complainant reported he was informed by the hospital about an incident involving df20 nc, lot 170406-0979.A physician wanted to perform a cardioversion on a patient of more than 100 kg of weight.Two attempts failed.They replaced the electrode with a quickcombo electrode from medtronic.They were able to perform the procedure then.The delay caused by the malfunction caused no harm to the patient.A sample of the same lot as the electrode involved in the incident is being sent to us.No further information had been made available to us despite repeated requestes.It was stated: "i will not receive any other answer from the customer before (b)(6).He left for holidays.".

• Brand Name: SKINTACT
• Common Device Name: DF20NC
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 6759451
• Report Number: 8020045-2017-00018
• Device Sequence Number: 11193353
• Product Code: MKJ
• UDI-Device Identifier: 19005531502915
• UDI-Public: (01)19005531502915
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 04/06/2020
• Device Model Number: SKINTACT
• Device Catalogue Number: DF20NC
• Device Lot Number: 170406-0979
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other