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U.S. Department of Health and Human Services

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

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LEONHARD LANG GMBH GS MULTIFUNCTION DEFIBRILLATION ELECTRODE Back to Search Results
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.
 
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Brand NameGS
Type of DeviceMULTIFUNCTION 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 Key11336429
MDR Text Key253835616
Report Number8020045-2021-00005
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NONE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
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 Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDF53NC
Device Catalogue Number05120.1 CORPATCH EASY PRE-CONN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
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 Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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