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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; MULTIFUNCTION DEFIBRILLATION ELECTRODE
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LEONHARD LANG GMBH SKINTACT; MULTIFUNCTION DEFIBRILLATION ELECTRODE Back to Search Results
Model Number DF59NC
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Retained samples of the concerned lot number were inspected visually and tested electrically for the function.All electrodes were within limits, no failure could be detected.The product is packaged in a way that the cable is lead out of the pouch so the electrode set can be connected to a defibrillator well before its use.The cable plus the pouch containing the electrode set are then placed in a further plastic bag to protect against tangling.The connector of the involved product (returned to us) appears to have been broken off about 2 cm above the cable.The initial reporter has stated that the connector was already broken when they opened the bag and that the bag did not contain any of the broken off pieces of the connector.We will provide a follow up report on the full results of the investigation of the involved customer sample.
 
Event Description
On (b)(6) 2019, we have been informed about a malfunction with a defibrillation electrode set at (b)(6) ambulance service in (b)(6).A defibrillation electrode set (model skintact df59nc) was about to be connected to a zoll defibrillator.Mr.(b)(6), who had filed the initial complaint at (b)(6) stated: "new packet opened at cardiac arrest and plug found broken, the broken bits were not in the packet", "due to this fault the clinician had to get the spare pad carried so delayed treatment by a min or two".The involved product was returned to us.There appears to have been no harm caused to the patient as a consequence of the delay in therapy.This is the assessment of mr.(b)(6), who stated in a phone conversation with us that he could not get any information.However, he then stated he assumed that nothing worse had happened to the patient as he would otherwise have been informed and in turn would have been required to report.No further information has been made available on this incident.
 
Event Description
On (b)(6)2019, we have been informed about a malfunction with a defibrillation electrode set at hart south west ambulance servicet in uk.A defibrillation electrode set (model skintact df59nc) was about to be connected to a zoll defibrillator.Mr.Abraham, who had filed the initial complaint at nhs, stated: "new packet opened at cardiac arrest and plug found broken, the broken bits were not in the packet", "due to this fault the clinician had to get the spare pad carried so delayed treatment by a min or two".The involved product was returned to us.There appears to have been no harm caused to the patient as a consequence of the delay in therapy.This is the assessment of mr.Abraham, who stated in a phone conversation with us that he could not get any information.However, he then stated he assumed that nothing worse had happened to the patient as he would otherwise have been informed and in turn would have been required to report.No furher information has been made available on this incident.
 
Manufacturer Narrative
Retained samples of the concerned lot number were inspected visually and tested electrically for the function.All electrodes were within limits, no failure could be detected.The product is packaged in a way that the cable is lead out of the pouch so the electrode set can be connected to a defibrillator well before its use.The cable plus the pouch containing the electrode set are then placed in a further plastic bag to protect against tangling.This further pouch is not zipped close.The connector of the involved product (returned to us) appears to have been broken off about 2 cm above the cable.The initial reporter has stated that the connector was already broken when they opened the plastic bag and that the bag did not contain any of the broken off pieces of the connector.We have carried out several tests on the plug of the same design.We found out if something heavy and hard (5kg) fell (30cm of height) on the plug, we were able to reproduce the reported error.However we were not able to determine what had caused such a damage at the user site.During the production run a 100% continuity test is performed including a control of the coding resistor.At the end of the assembly line the plug is connected into a test gauge a second time for reading out the coding resistor.Afterwards the products are finally inspected visual and packed into the pouches and the transparent anti-tangling plastic bag and placed in a box (of 10 electrodes).As the product is packaged with the cable lead out of the pouch, any damage to the connector would remain visible to the worker when boxing the product.We are therefore certain that no damaged connector was packaged.The user had remarked that no debris of the broken connector was found in the anti-tangling plastic bag.As this bag is not closed but only folded over upon packaging, it is not indicative that the damage was incurred at our premises.The connector might as well have been damaged at the user's facility and the debris might have fallen out of the plastic bag (which is folded over but not zipped close).No further conclusion can be drawn as to what might have caused the customer problems.
 
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Brand Name
SKINTACT
Type of Device
MULTIFUNCTION DEFIBRILLATION ELECTRODE
Manufacturer (Section D)
LEONHARD LANG GMBH
archenweg 56
innsbruck, 6020
AU  6020
MDR Report Key8611765
MDR Text Key161776000
Report Number8020045-2019-00010
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier190005531506446
UDI-Public(01)190005531506446
Combination Product (y/n)N
PMA/PMN Number
K142803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/10/2021
Device Model NumberDF59NC
Device Lot Number180410-0979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Date Manufacturer Received04/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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