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

Model Number DF23T

Device Problems Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)

Patient Problems Unspecified Heart Problem (4454); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/13/2024

Event Type  Death  

Event Description

On march12th, 2024, we have been informed about a malfunction with a defibrillation electrode set at rettungsdienst wittmund in germany.Gs defibrillation electrodes catalogue number 04324.3 corpatch easy (schale) (model df23t) and a gs corpuls c3 defibrillator had been used.The initial report was stating that [translated from german language to english language "in a resuscitation situation, close to connecting and attaching the [defibrillation] electrodes, the device reported in the defi mode "connect therapy electrodes." the user then disconnected and reconnected the connection between the electrodes and master cable several times, restarted the device, no improvement.The patient could then be treated with the emergency ambulance car device (lifepack).[gs corpuls has received the concerned customer samples and informed us that:] we analyzed and checked the ambulance data [recorded by the defibrillator] and the concerned electrodes.We were able to detect the error described.A resistance measurement on the 4 outer contacts showed: right side: 10.97 k ohms, left side: 13.7 m ohms." later on we have received a partially filled in questionnaire stating that the concerned defibrillation electrode was stored dry and warm in the emergency ambulance car and were opened 1 minute prior before usage.No additional gel was used and no shock was delivered with defibrillation paddles.A gs corpuls c3 defibrillator was used in a biphasic manual mode.The male patient was described as 71 years old, normal built with a weight of 75kg.The patient skin was normal and cold.No skin preparation was performed prior applying.It was stated that the skin was not shaven, not dried, not disinfected and no lotions or creams have been used.Further on it was reported that the defibrillation electrodes adhered well to the patient skin and isolated hairs were underneath the defibrillation electrode.The defibrillation electrodes have not been repositioned and the patient was also not repositioned.After requesting the patient health status we have been informed that "the patient is presumably deceased.The patient could continue to be treated with the nef device." no further details have been disclosed so far.

Manufacturer Narrative

This product is not marketed in the usa.No 510 (k) and no pma exist for it.However, devices made using a similar design are sold in the us.We are therefore reporting this incident.Retained samples of the concerned lot number 211215-3997 have been inspected visually and tested electrically.All tested electrodes were within limits, no failure could be detected.The device involved in the incident is being shipped to us and will be examined once we receive it.Currently no conclusion can be drawn what might have caused the incident.Additional data are being requested (operational data records of the defibrillator).We will relay an additional results in a follow up report.

Manufacturer Narrative

This product is not marketed in the usa.No 510 (k) and no pma exist for it.However, devices made using a similar design are sold in the us.We are therefore reporting this incident.Retained samples of the concerned lot number 211215-3997 have been inspected visually and tested electrically for the function.All tested electrodes were within limits, no failure could be detected.On april 17th, 2024 the involved device was received in an open pouch.It was disinfected and then inspected.A visual inspection of the defibrillation electrode set showed no obvious damage.The connector of the involved electrode set was also visually inspected.Neither damages nor deviations were visible.An electrical continuity test was performed using a multimeter to test for electrical continuity.Initially the pins of the connector were touched but no pressure was exerted.Both leads as well as the coding resistor in the connector had continuity.Pressure was then applied to the measuring tips during measurement on the contacted connector.These tests revealed that the coding resistor's value changed and did not remain constant.The root cause was identified to be the method (crimping) the resistor was connected with to the respective coding resistor pins.As a corrective action implemented march 01st, 2023 the resistor is now being connected to the coding resistor pins with a soldering process.The reported issue affects a lot which was produced before the corrective action was taken.However we have requested further information for the cause of the patient death and have been informed that [translated from german language to english language]: "the delay in therapy was not the cause of the patient's death".The ifu states that "always keep a second pack of electrodes with the defibrillator".The user stated: "an emergency vehicle arrived at the scene promptly.The replacement electrode was provided by the emergency vehicle of another district, which however uses the lifepack 15.According to the user, replacement electrodes were available; these were connected and recognized after use, so that a device error could be excluded." we therefore consider the investigation and the report closed.

Event Description

On march12th, 2024, we have been informed about a malfunction with a defibrillation electrode set at (b)(6) in germany.Gs defibrillation electrodes catalogue number 04324.3 corpatch easy (schale) (model df23t) and a gs corpuls c3 defibrillator had been used.The initial report was stating that [translated from german language to english language "in a resuscitation situation, close to connecting and attaching the [defibrillation] electrodes, the device reported in the defi mode "connect therapy electrodes".The user then disconnected and reconnected the connection between the electrodes and master cable several times, restarted the device, no improvement.The patient could then be treated with the emergency ambulance car device (lifepack).[gs corpuls has received the concerned customer samples and informed us that] we analyzed and checked the ambulance data [recorded by the defibrillator] and the concerned electrodes.We were able to detect the error described.A resistance measurement on the 4 outer contacts showed: right side: 10.97 k ohms.Left side: 13.7 m ohms".Later on we have received a partially filled in questionnaire stating that the concerned defibrillation electrode was stored dry and warm in the emergency ambulance car and were opened 1 minute prior before usage.No additional gel was used and no shock was delivered with defibrillation paddles.A gs corpuls c3 defibrillator was used in a biphasic manual mode.The male patient was described as 71 years old, normal built with a weight of 75kg.The patient skin was normal and cold.No skin preparation was performed prior applying.It was stated that the skin was not shaven, not dried, not disinfected and no lotions or creams have been used.Further on it was reported that the defibrillation electrodes adhered well to the patient skin and isolated hairs were underneath the defibrillation electrode.The defibrillation electrodes have not been repositioned and the patient was also not repositioned.After requesting the patient health status we have been informed that "the patient is presumably deceased.The patient could continue to be treated with the nef device." no further details have been disclosed.

• Brand Name: GS
• Type of Device: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 19085966
• MDR Text Key: 339875967
• Report Number: 8020045-2024-00006
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 19005531505296
• UDI-Public: (01)19005531505296
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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
• Device Operator: Health Professional
• Device Model Number: DF23T
• Device Catalogue Number: 04324.3 CORPATCH EASY (SCHALE
• Device Lot Number: 211215-3997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 75 KG