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

Model Number DF53NC

Device Problem Device Sensing Problem (2917)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

As neither customer samples nor the involved lot number were provided for this incident, no tests could be performed.Despite of repeated requests from us, the initial reporter was not able to supply us with more information on the involved product.We have been informed on (b)(6) 2021 that: "evaluation of defibrillator recording data: the evaluation of the defibrillator recording data shows that the contacted electrode was not reliably recognized (cable code).The electrode was in contact with the patient at all times.The patient impedance was measured correctly.Checking the device: when checking the device / accessories, no defect was found on the device.Conclusion / possible causes: the user did not fully insert the electrode cable into the therapy connection of the device electrode coding in the connector was not reliable as no further informaiton was provided despite repeated requests further no conclusion regarding the cause can be drawn.The initial reporter has informed us that "we will close the complaint on our side".We therefore also close the complaint.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.

Event Description

On (b)(6) 2021 , we have been informed about a malfunction with a defibrillation electrode set at an unknown rescue service in the netherlands.Gs defibrillation electrodes catalogue number 05120.1 corpatch easy pre-connected (model df53c) and a gs corpuls defibrillator (model unknown) had been used.The initial report is stating that "during a cpr mission in the netherlands, the emergency services were unable to immediately defibrillate the patient.According to our analysis, the electrode used (p / n 05120.1, your p / n 50530 "corpatch easy pre-connected") was not correctly recognized.The device has been checked and a device defect can be excluded.The electrodes as well as the packaging were disposed of by the user and are not available for further analysis." in a later communication it was reported that: after applying the defibrillation electrodes, the user had a dashed line on the display and no shock was possible; the defibrillator displayed the message: no contact with the pads or cables are broken.After shaking the cable, the plug and the defibrillation unit a contact was detected immediately; the evaluation of the defibrillator recording data showed that after shaking all components an ecg signal, the patient impedance and the cable coding were detected.The cpr treatment was continued with the corpuls3 defibrillator and defibrillation electrodes of a second ambulance.After several requests if the patient was harmed in the incident it was reported that "no patient damage was reported to us." we asked again about the patient outcome and were informed by the initial reporter that despite repeated inquiries, no statement was made available what happened to the patient after he was handed over to the hospital.

• 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: 11336429
• MDR Text Key: 253835616
• Report Number: 8020045-2021-00005
• Device Sequence Number: 1
• Product Code: MKJ
• 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: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DF53NC
• Device Catalogue Number: 05120.1 CORPATCH EASY PRE-CONN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other