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

Model Number	DF29N
Medical Device Problem Codes	Fitting Problem (2183); Insufficient Device Problem Information (3190)
Date of Event	08/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The retained samples have been inspected visually, tested electrically and mechanically.All samples were found to perform within limits.No faults could be detected.Reviewing the returned electrode set we detected no visual deviation.An electrical test with a multimeter was performed.This test was performed on all metal components: the connector, the cable, the rivet and the electrode itself.Thereby we detected no electrical failure of the metallic components.We have send the involved sample to the medical university innsbruck, department of radiology for further x-ray investigation to visualize a possible failure without destroying the connector respectively the cable.Actually we have not received the investigation results.We will provide a follow-up report as soon as these results get available.
Event or Problem Description
On august 11th, we have been informed about a malfunction with a defibrillation electrode at hospital (b)(6).An unknown defibrillator and a skintact defibrillation electrode set (df27n) were used at the cardiology intensive.The initial report disclosed that "when they connected a pair of this lot on the equipment there was no defibrillation.They changed the equipment and had the same no result.They moved the cables on the electrodes side and had result !" the malfunction caused no harm or impact to the patient.No further information's on the procedure and the generator model have been disclosed so far.

• Brand Name: SKINTACT
• Common Device Name: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 5945518
• Report Number: 8020045-2016-00020
• Device Sequence Number: 13600707
• Product Code: MKJ
• UDI-Device Identifier: 19005531506388
• UDI-Public: (01)19005531506388(10)60323-0775(17)190323
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/19/2016

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: 05/31/2016
• Device Model Number: DF29N
• Device Catalogue Number: DF27N
• Device Lot Number: 60502-0779
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/30/2016
• 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