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

Model Number	DF29N
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The retained samples of the same lot number have been inspected visually and tested electrically.All samples were found to perform within limits.No faults could be detected.The retained samples were trialed for connector fit with a defibrillator welch allyn aed10.When trying to insert the retained samples into the defibrillator, electrical connection was established but the holding nose of the connector was not locking.However, as an electrical connection was achieved, the defibrillator automatically proceeded to the next step ("analyzing heart rhythm").Pictures provided by the reporters show a connector inserted into the aed's socket in a way that always resulted in pad recognition and the making available of defibrillation by a defibrillator of the same model during the investigation at the manufacturer's site.Unfortunately the product involved in the event was discarded by the users.Further analyses of the connectors have been initiated.The user facility is in the process of replacing the involved defibrillator.They are willing to make the involved defibrillator available to us once the transition is made.We will relay further results of our investigation on the root cause and any conclusions we might draw as well as any further clarification regarding the cause of the patient's death in a follow up report as soon as possible.
Event or Problem Description
On august 1st, we have been informed about an adverse event with a defibrillation electrode set, model df29, at (b)(6) - assisted living.On (b)(6) in the late afternoon (two different p.M.Times were indicated), an approximately (b)(6) resident required treatment with a defibrillator.A "cpr/aed trained staff member was unable to make skintact aed electrodes connect to welch allyn aed 10 machine.Clip was resistant to push and felt as if ends were not matched." "our staff performed cpr and ems did provide defibrillation very quickly after arrival" (with their defibrillator).The electrode was thrown away.The defibrillator will be made available for further analysis.The patient "passed away sometime during the night of (b)(6) in icu at our local hospital." "his death was caused by complications related to a cardiac arrest (we believe, but again do not have medical records).(.) there is no doubt in anyone's mind that this was a natural cause of death despite all efforts." we are trying to obtain more information to determine whether the adverse event was in any way causal or contributive to the patient's death.
Additional Manufacturer Narrative
The retained samples of the same lot number have been inspected visually and tested electrically.All samples were found to perform within limits.No faults could be detected.The retained samples were trialed for connector fit with a defibrillator welch allyn aed10.When trying to insert the retained samples into the defibrillator, electrical connection was established but the holding nose of the connector was not locking.However, as an electrical connection was achieved, the defibrillator automatically proceeded to the next step ("analyzing heart rhythm").Pictures provided by the reporters show a connector inserted into the aed's socket in a way that always resulted in pad recognition and the making available of defibrillation by a defibrillator of the same model during the investigation at the manufacturer's site.Unfortunately the product involved in the event was discarded by the users.Further analyses of the connectors have been initiated.The user facility has made the involved defibrillator available to us.The ongoing investigation of a defibrillator of the same model and defibrillation electrodes df29n have raised usability concerns.These concerns have intensified after an initial investigation of the involved defibrillator.We have therefore decided to recall all defibrillation electrodes model df29n.Further results of our investigation will be provided in a follow-up report.
Event or Problem Description
On august 1st, we have been informed about an adverse event with a defibrillation electrode set, model df29, at vista - assisted living wing of mission ridge retirement community in billings mt.On (b)(6) in the late afternoon (two different p.M.Times were indicated) an approximately (b)(6) resident required treatment with a defibrillator.A "cpr/aed trained staff member was unable to make skintact aed electrodes connect to welch allyn aed 10 machine.Clip was resistant to push and felt as if ends were not matched." "our staff performed cpr and ems did provide defibrillation very quickly after arrival" (with their defibrillator).The electrode was thrown away.The defibrillator will be made available for further analysis.The patient "passed away sometime during the night of (b)(6) in icu at our local hospital." "his death was caused by complications related to a cardiac arrest (we believe, but again do not have medical records).(.) there is no doubt in anyone's mind that this was a natural cause of death despite all efforts." we are trying to obtain more information to determine whether the adverse event was in any way causal or contributive to the patient's death.

• Brand Name: SKINTACT
• Common Device Name: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 5902787
• Report Number: 8020045-2016-00018
• Device Sequence Number: 16257547
• Product Code: MKJ
• UDI-Device Identifier: 19005531500287
• UDI-Public: (01)19005531500287(10)41008-0778(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K142803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: DF29N
• Device Lot Number: 41008-0778
• Was Device Available for Evaluation?: No
• Event Location: Nursing Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2016
• Supplement Report FDA Received Date: 09/06/2016
• 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: Death; Life Threatening; Other
• Patient Weight: 73