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

Model Number DF87C

Device Problems Failure to Analyze Signal (1539); Device Sensing Problem (2917)

Patient Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Event Description

On may 04th, 2023, we have been informed by ansm about a malfunction with a defibrillation electrode set at the s.D.I.S.95 service departemental (fire brigade paris) in france.Schiller defibrillation electrodes catalouge number 0-21-0040 (model df87c) and a schiller defibrillator had been used.During an emergency situation an electrode was discovered that showed a malfunction.The complainant reported [translated from french language to german language to english language]: "description of the incident: triggering of the rescue measures firefighters from mery/o for a patient in auvers/o.The patient was found at home in cardiac arrest by our firefighters.Use of the dsa dgt7 with original electrodes: the device does not recognize the electrodes, so generic electrodes had to be used.Information about the patient: current patient condition: the defibrillator does not recognize the pads, resulting in an inability to deliver a shock when needed.[sic] measures taken in the healthcare facility to treat the patient: application of emergency electrodes, which are recognized by the defibrillator - after the device is switched off.[sic] [original french text: actions entreprises dans l'établissement de soins pour la prise en charge du patient : mise en place d'électrodes de secours, reconnues par le défibrillateur après débranchement.]" we have requested further information on the malfunction and the impact of the malfunction on the patient as well as the involved sample for investigation.No further details have been disclosed so far.

Manufacturer Narrative

Retained samples of the concerned lot number 220404-4018 have been inspected visually and tested electrically for the function.All tested electrodes were within limits, no failure could be detected.The involved device has not been made available to us.We have requested information on the patient outcome and the malfunction, the involved device and customer samples from the concerned lot number.Currently no conclusion can be drawn what might have caused the incident.

Manufacturer Narrative

Retained samples of the concerned lot number 220404-4018 have been inspected visually and tested electrically for the function.All tested electrodes were within limits, no failure could be detected.The involved device has not been made available to us.We have requested information on the patient outcome and the malfunction, the involved device and customer samples from the concerned lot number and have been informed on august 29th, 2023 that [translated from german to english language]: "we have traced the error to the device defigard touch-7.It is an electronic error, the electrodes are not involved." we additonally received the manufacturer incident report (mir) for serious incidents filled in by company schiller medical (defibrillator manufacturer).Within this report it is specifyied [translated from french to english language]: "the user's first hypothesis, concerning a fault in the defibrillation electrodes, was contradicted by the expertise of the intervention logs.We requested the return of the device for expertise.During simulator tests, it was impossible to start the analysis.Ecg waveforms are only displayed on part of the screen but restart instantly.In the logs during the intervention, the device was used in semi-automatic defibrillation mode.He repeated in a loop "do not touch the patient again, analysis in progress.".On the impedance trace, several peaks at 501 ohm are observable (electrode faults).The fault is an electronic fault, which is located on the ecg part of the cpu board." no faults concerning the investigated retained samples could be detected.Based on the investigation results by company schiller medical no failure caused by the electrode has occurred.We therefore consider the investigation closed.

Event Description

On may 04th, 2023, we have been informed by ansm about a malfunction with a defibrillation electrode set at the s.D.I.S.95 service departemental (fire brigade paris) in france.Schiller defibrillation electrodes catalouge number 0-21-0040 (model df87c) and a schiller defibrillator had been used.During an emergency situation an electrode was discovered that showed a malfunction.The complainant reported [translated from french language to german language to english language]: "description of the incident: triggering of the rescue measures firefighters from mery/o for a patient in auvers/o.The patient was found at home in cardiac arrest by our firefighters.Use of the dsa dgt7 with original electrodes: the device does not recognize the electrodes, so generic electrodes had to be used.Information about the patient: current patient condition: the defibrillator does not recognize the pads, resulting in an inability to deliver a shock when needed.[sic] measures taken in the healthcare facility to treat the patient: application of emergency electrodes, which are recognized by the defibrillator - after the device is switched off.[sic] [original french text: actions entreprises dans l'établissement de soins pour la prise en charge du patient : mise en place d'électrodes de secours, reconnues par le défibrillateur après débranchement.]" we have requested further information on the malfunction and the impact of the malfunction on the patient as well as the involved sample for investigation.

• Brand Name: SCHILLER
• 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: 17000843
• MDR Text Key: 315918505
• Report Number: 8020045-2023-00013
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 19005531508129
• UDI-Public: (01)19005531508129
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142803
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DF87C
• Device Catalogue Number: 0-21-0040
• Device Lot Number: 220404-4018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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