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

Model Number DF56

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Death (1802); Unspecified Heart Problem (4454)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the usa.However, there are products which are similar in construction and sold in the us.We are therefore considering the incident reportable.Retained samples of the concerned lot number 190912-4047 were inspected visually and tested electrically for the function and mechanically.All electrodes were within limits, no failure could be detected.We immediately have contacted schiller (b)(4), the manufacturer of the defibrillator and the distributor of the electrode, about this complaint.Schiller has informed us that the affected defibrillator with the affected defibrillation electrode has been requested by them for further investigating the root cause.We will get the involved electrode set for investigation.We will follow up once we receive further information from the investigation of schiller medical and once our investigation of the involved defibrillation electrode set is completed.

Event Description

On august 3rd, 2020 we have been informed about an incident with a defibrillation electrode set at (b)(6).Schiller defibrillation electrodes (model df27n) and a schiller defigard touch 7 defibrillator had been used.The complainant stated that [translated from french to (b)(6) then to english language]: "taking care of a man, (b)(6), with cardiac arrest who was massaged by a witness.Connect the defibrillator.The analysis recommends delivering a shock.The shock will not initially be delivered because the device has detected an electronic problem and a "safety discharge" has been performed.The shock is delivered 2 minutes later, after re-analysis.Information about the patient: the shock is delivered with a delay of 2 minutes delayed analysis of the rhythm after the 1st shock the person is then taken over by another paramedic team (samu) with another device and cared for: several shocks are delivered, the patient dies.Two lot numbers of electrodes were stated as concerned in the initial report: 190912-4042 and 190912-4047.The lot number 190912-4042 does not exist.

Manufacturer Narrative

This product is not marketed in the usa.However, there are products which are similar in design sold in the us.We therefore consider the incident reportable.Two lot numbers of electrode sets were stated as concerned in the initial report: 190912-4042 and 190912-4047.The lot number 190912-4042 does not exist.On (b)(6) 2020, we have received the involved samples for further investigation.A sample each of a lot numbers 190912-4047 and 190502-0779 were received.We therefore know that the second concerned lot number is 190502-0779.Retained samples of the concerned lot numbers 190912-4047 and 190502-0779 were inspected visually and tested electrically for the function and mechanically.All electrodes were within limits, no failure could be detected.The returned involved samples of both lot numbers were disinfected on (b)(6) 2020 as both sets had been applied to the patient.Investigating the involved sample of lot number 190912-4047 no visual deviations could be detected on both electrodes.The continuity of both electrodes was tested using a multimeter.Measurements were made from the cable connector to the gel / tin foil of the electrodes.Without any movement, both electrodes had a continuity and no signal interference could be detected.The cable was then moved near the ring eyelet while measuring continuity.No continuity or signal interference could be found.Investigating the involved sample of lot number 190502-0779 visually: the foam rivet cover of the minus electrode (blue cable) was lifted off in the area of the cable exit.The cable was still adequately fixed.No deviation of the riveting itself could be determined.The foam rivet cover of on the plus electrode (white cable) was badly damaged in the area of the cable exit.When the foam rivet cover was peeled off, no deviations in the riveting itself could be determined but the riveting was no longer tight.The continuity of both electrodes was tested using a multimeter.Measurements were made from the cable connector to the gel / tin foil of the electrodes.Without any movement, no continuity failure could be detected.The cable was then moved near the ring eyelet while measuring continuity.No signal interference could be detected at the minus electrode.At the plus electrode a signal interference up to temporary signal loss was detected when moving the cable.We assume that mechanical stress exerted on the cable must have led to the observed damages of the electrodes.The signal problems at the minus electrode of lot number 190502-0779 most likely is the consequence of the mechanical damage.The investigation by the defibrillator manufacturer schiller france sas determined that the complaint was caused by the involved defibrillator.It was detected by schiller france sas that an electronic error was the root cause for the complaint.The electrode was applied to the patient.The defibrillator performed analysis on the patient and then determined the patient had to be resuscitated.The shock was not initially delivered because the device had detected an electronic problem and a "safety discharge" was performed.There was no deviation or failure of the electrode recorded.It is conceivable that the user was unsettled due to the defibrillator error and has pulled on the cable and / or the electrode to remedy the situation, thereby causing the mechanical damage on the foam cover of the rivet and the riveting itself.No further conclusion can be drawn.We therefore close the investigation.

Event Description

On (b)(6) 2020 we have been informed about an incident with a defibrillation electrode set at s.D.I.S.44 service department, france.Schiller defibrillation electrodes (model df27n) and a schiller defigard touch 7 defibrillator had been used.The complainant stated that [translated from french to german then to english language]: "taking care of a man, 59 years old, with cardiac arrest who was massaged by a witness.Connect the defibrillator.The analysis recommends delivering a shock.The shock will not initially be delivered because the device has detected an electronic problem and a "safety discharge" has been performed.The shock is delivered 2 minutes later, after re-analysis.Information about the patient: the shock is delivered with a delay of 2 minutes; delayed analysis of the rhythm after the 1st shock; the person is then taken over by another paramedic team (samu) with another device and cared for: several shocks are delivered, the patient dies.Two lot numbers of electrodes were stated as concerned in the initial report: 190912-4042 and 190912-4047.The lot number 190912-4042 does not exist.

• Brand Name: SCHILLER
• Type of Device: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10395263
• MDR Text Key: 238335749
• Report Number: 8020045-2020-00018
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 19005531504459
• UDI-Public: (01)19005531504459
• Combination Product (y/n): N
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: DF56
• Device Catalogue Number: 2.155061
• Device Lot Number: 190912-4047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 59 YR