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

Model Number	DF59N
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The retained samples of the same lot number have been inspected visually and tested mechanically.All samples were found to perform within limits.No faults could be detected.As we will send a product specialist to the complaining user facility, we will report further results of our investigation in a follow-up report.Device not returned.
Event or Problem Description
On october 19th, we have been informed about a potential malfunction with a defibrillation electrode set, model df59nc, at an unknown customer, most likely in (b)(6).The initial report stated the user had damaged the connectors of two defibrillators when attempting to connect the defibrillation electrode.On october 25th, we received a correction to the extent that the electrode model involved was df59n and not df59nc.No patient was harmed.We will send a product specialist to the complaining user site to investigate the complaint.
Additional Manufacturer Narrative
The retained samples of the same lot number have been inspected visually and tested mechanically.All samples were found to perform within limits.No faults could be detected.A product specialist visited the complaining user facility on december 21.He was able to verify a fit problem with the defibrillator at site and the electrodes df59n but not with defibrillators he had taken with him as references.It was also not possible to replicate the problem with defibrillation electrodes model df59nc.After the visit, it was attempted to get the involved defibrillators for further investigation of the sockets.The complainant informed us in march that he was not willing to provide the defibrillator.It was decided to procure zoll defibrillators of a more recent built than the models at hand for further investigations.Usability studies conducted with these machines and further investigation revealed that defibrillation electrodes df59 and df59nc with a connector used in assemblies till 2015 have a potential fit problem with zoll aed plus machines manufactured in recent years due to dimensional variations in the defibrillators' electrode cable socket.It was decided to recall the electrodes affected.Device not returned.
Event or Problem Description
On (b)(4), we have been informed about a malfunction involving a defibrillation electrode set, model skintact df59n, and a zoll aed plus at (b)(4).The initial report stated the user had damaged the connectors of two defibrillators during a trial when attempting to connect the defibrillation electrodes to two zoll aed plus defibrillators.No patient was harmed.

• Brand Name: SKINTACT
• Common Device Name: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 6123883
• Report Number: 8020045-2016-00026
• Device Sequence Number: 812717
• Product Code: MKJ
• UDI-Device Identifier: 19005531506432
• UDI-Public: (01)19005531506432(10)50403-0772(17)180430
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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: 04/30/2018
• Device Model Number: DF59N
• Device Catalogue Number: DF59N
• Device Lot Number: 50403-0772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 08/07/2017
• 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