MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; MULTIFUNCTION DEFIBRILLATION ELECTRO

Model Number DF27N

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

On (b)(6), we have been informed about a potential malfunction with a defibrillation electrode and a laerdal heartstart fr2+ defibrillator.A pt suffered a cardiac arrest.It was reported that when the ambulance crew started cpr the defibrillator stated that it couldn't analyze.This happened twice more (after 2 min intervals).When more ambulance personnel arrived, the defibrillator was replaced, the electrodes were not replaced.Then it worked.The first defibrillator has been inspected afterwards but worked properly.The malfunction was recognized during the procedure which lasted for 30 mins.No pt injury was reported.The pt was described as slim and the skin type as normal.The pt was lying on the back.The pt skin was not cleaned, shaven, dried, disinfected and no ointment had been used.The electrode was adhering well to the pt skin and no repositioning of the applied electrodes were necessary.We have not rec'd any further info so far despite of repeated requests.

Manufacturer Narrative

Two different lot numbers were provided but not indicated, which one was involved in the incident.These are 40922-0774 or 40918-0771.Retained samples of both lot numbers were inspected visually and tested electrically.The tested devices were found to perform within limits.No faults could be detected.Actually, we are not sure if a malfunction was caused by the defibrillation electrodes used as a rep of the ambulance svc ((b)(4)) stated "(.) the crew changed defibrillator when more ambulance personnel arrived, not the electrodes.Then it worked (.)".We have been asking for add'l info on the incident regarding the model of the 2nd defibrillator used, whether the electrodes had been already placed on the pt when the first defibrillator indicated "no analysis possible", whether the pt was defibrillated, whether the pt was injured due to the therapy delay and how the pt is doing now.We will provide you with this info in a follow up report, once we receive it.

Manufacturer Narrative

A product specialist met with the complaining customer to further investigate the claimed failure.Based on the manual of the defibrillator the specific error message is not triggered by an electrode malfunction but by other causes.It turned out, the customer had not retrieved the log file from the defibrillator but will try to do so now to confirm the conclusion.

• Brand Name: SKINTACT
• Type of Device: MULTIFUNCTION DEFIBRILLATION ELECTRO
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck 6020 ; AU 6020
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck 6020 ; AU 6020 ; 12334257
• MDR Report Key: 4844430
• MDR Text Key: 16307999
• Report Number: 8020045-2015-00046
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K072233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: DF27N
• Device Lot Number: 40922-0774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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 Age: 22 YR