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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 DF23T
Device Problem Device Sensing Problem (2917)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
As neither customer samples nor the involved lot number were provided for this incident, no tests on the involved lot number could be performed. The initial reporter was able to limit all lot numbers which have been delivered to the rescue service in the last year till february 18th, 2021. Five possible affected lot numbers have been identified: 200602-3994, 200311-3998, 200205-3994, 200205-3994, 200108-3992. The retained samples of all five possible concerned lot numbers have been inspected visually, tested electrically according to relevant clauses of ansi/aami df80. All samples were found to perform within limits. No faults could be detected. Also an electrical test with a multimeter was performed. This test was performed on all metal components: the connector, the cable, the rivet and the electrode itself. Thereby we detected no electrical failure of the metallic components. The initial reporter has provided the defibrillator recording data [translated from german to english language]: according to the defibrillator recording it can be seen that the electrode was reliably recognized by the cable code "4" (
=
disposable adhesive electrodes "corpatcheasy" for adults). In the measurement of the patient impedance as well as in the recorded ecg signal, short interruptions can be recognized over and over again during the entire period of use (electrode loose). Charging the defibrillator was aborted triggered by a loose electrode alert, the incomplete charge was discharged internally. After re-charging the shock was successfully delivered to the patient. This sequence repeated two more times. During the entire mission, 4 shocks with 200 joules each were delivered to the patient. The measured patient impedance was between 73 and 80 ohms immediately before the shock. Examination of the used defibrillator: the patient impedance measuring circuit was intensively checked, dismantling of the assemblies, visual and functional check no abnormalities, no loose contact recognizable. No abnormalities were observed after assembly and the subsequent "safety checks". No device failure or defects could be detected. As the involved electrode was discarded by the rescue team no conclusion can be drawn what might have caused the problems and if the used defibrillation electrodes were faultless. The initial reporter has informed us that no further information is available on the defibrillator records respectively the rescue team. All information have been provided. Without investigating the involved device we cannot conduct any further investigation. We therefore 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 germany. Gs defibrillation electrodes catalogue number p/n 04324. 3ba corpatch easy (model df23t) and a gs corpuls defibrillator (model c3) had been used. The initial report provided the information that a patient had ventricular fibrillation and had to be resuscitated. It was reported that during permanent resuscitation, the first energy charge did not work right away, charging was stopped or canceled. 200 j were not reached during the charge. At about 80% the c3 stopped. After entering the joule number again and pressing the load button, defibrillation was possible. Further defibrillations were possible without any problems. The defibrillator recording data shows that the joule have been displayed sometimes clearly readable and sometimes hatched. The electrodes have stuck to the patient reliable and no impairment of patient hair have been reported. Further defibrillations worked without any problems. The start difficulties resulted in a delay in therapy. There were 47 seconds between the activation of the defibrillator and the release of the first shock. No patient injury was reported there was only a delay in treatment.
 
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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 Key11503538
MDR Text Key253837237
Report Number8020045-2021-00010
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 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDF23T
Device Catalogue Number04324.3BA CORPATCH EASY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2021
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: 03/17/2021 Patient Sequence Number: 1
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