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

Model Number 04324.3

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

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.A 100% continuity test is performed on each electrode set in production before packaging.As the device had not been returned for investigation and no photos had been taken, the only source of information was a phone interview (on june 11) with one of the two paramedics involved in the incident.He described the cable appearing to have been cut through.He stated that no strands had been visible protruding from the cable's insulation.This supports the theory that the cable had been cut through.The internal investigation as whether there is any possibility that a cable can get cut in the assembly or packaging process at leonhard lang is still ongoing.We will provide a follow-up report.

Event Description

On may 16th, 2019, we have been informed about a malfunction with a defibrillation electrode set at (b)(6).A defibrillation electrode set (model gs corpatch easy, model number 04324.3) was about to be connected to a gs defibrillator corpuls 3.Mr.(b)(6), who had filed the initial complaint to the (b)(6), stated: when unpacking the defibrillation electrodes from the packaging one electrode was detected to be not connected / soldered to the cable.A defibrillation was thus not possible.Patient has not suffered any damage since defibrillation electrodes from the ambulance vehicle were subsequently used.Requesting the involved device for further investigation, we received the information that the paramedics did not take the involved electrode with them or made any pictures of the defect.The involved electrode could not be recovered.We were able to contact one of the paramedics involved in the incident and had a telephone conversation.The paramedic stated his colleague had opened the tray of the electrode immediately prior to usage.He detected that the cable of the apex electrode was cut directly at the electrode.On the electrode no piece of a remaining cable was visible.The cable was cut smoothly through insulation and core, no cable strands were protruding from the insulation.

Event Description

On (b)(6)2019, we have been informed about a malfunction with a defibrillation electrode set at malteser hilfsdienst gemeinnützige gmbh koblenz in germany.A defibrillation electrode set (model gs corpatch easy, model number 04324.3) was about to be connected to a gs defibrillator corpuls 3.Mr.Kaufmann, who had filed the initial complaint to the german authority bfarm, stated: when unpacking the defibrillation electrodes from the packaging one electrode was detected to be not connected / soldered to the cable.A defibrillation was thus not possible.Patient has not suffered any damage since defibrillation electrodes from the ambulance vehicle were subsequently used.Requesting the involved device for further investigation, we received the information that the paramedics did not take the involved electrode with them or made any pictures of the defect.The involved electrode could not be recovered.We were able to to contact one of the paramedics involved in the incident and had a telephone conversation.The paramedic stated his colleague had opened the tray of the electrode immediately prior to usage.He detected that the cable of the apex electrode was cut directly at the electrode.On the electrode no piece of a remaining cable was visible.The cable was cut smoothly through insulation and core, no cable strands were protruding from the insulation.

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.A 100% continuity test is performed on each electrode set in production before packaging.As the device had not been returned for investigation and no photos had been taken.Beyond the initial report, the only source of information was a phone interview (on june 11) with one of the two paramedics involved in the incident.He described the cable appearing to have been cut through.He stated that no strands had been visible protruding from the cable's insulation.A review of the electrode assembly and packaging line was performed.The way the components and then the assembled electrode sets are handled and separated at several steps in the process makes it inconceivable that a cut through cable is not noticed during assembly.In addition, in the entire assembly line no blades or sharp objects are used or are present, which could create such a cut.Furthermore, cutting a wire would result in one of the two electrodes becoming severed from the set and thus next to impossible to be packaged into the case.We are therefore convinced that the damage to the electrode set (cut wire) had neither happened during assembly nor during packaging.As the involved device was discarded at the scene of the incident no further investigation can be performed regarding the involved device or its components.No further conclusion can be drawn what might have caused the failure.We therefore close the investigation and the report.

• Brand Name: GS
• Type of Device: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 8691064
• MDR Text Key: 201375001
• Report Number: 8020045-2019-00013
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 190005531505296
• UDI-Public: (01)190005531505296
• Combination Product (y/n): N
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: 04324.3
• Device Catalogue Number: CORPATCH EASY
• Device Lot Number: 180105-0792
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR