MAUDE Adverse Event Report: 3M INFECTION PREVENTION 3M DEFIB PADS; CONDUCTIVE GEL

Model Number N/A

Device Problems Failure to Conduct (1114); Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Death (1802); Sudden Cardiac Death (2510)

Event Date 08/24/2017

Event Type  Death  

Manufacturer Narrative

No lot number was provided.Without lot number you can not determine expiration date or manufacturer date.This complaint is linked to 2110898-2017-00130.Since a different product was used and replaced the product used under this complaint.2110898-2017-00130 used 2345n and this complaint 2110898-2017-00131 used 2346n.The patient was the same.The information received indicated four shocks were give within 20 minutes but it was not clear how many shocks used 2345n and 2346n.Product 2345n under this complaint was not returned.This is a very rare occurrence and event.Investigation is ongoing.

Event Description

A male patient in cardiac arrest underwent defibrillated using 3m defib pads (consisting of electro conductive gel).There was no sign of electric conductivity during second or third defibrillation nor a response from the patient.Patient subsequently died.It was confirmed the defibrillators used with these specific defibs pads worked according to the manufacturer's specifications.

Manufacturer Narrative

There was no lot number given nor was the product used returned.It is difficult to review product release data to make sure product involved in the reported incident met all its release criteria.Based on review of complaints for two years there has only been one report of this type of event for this specific model and it is this one being submitted to fda.However, the hospital biomed engineer indicated the hardware including defib pads were examined and functioned in the correct way.The method used was not disclosed but the assumption is they may have performed a visual and touch for wetness regarding the defib pads.This report is linked to 2110898-2017-00130 for it involved the same patient but the use of a different model product and one that did include a specific reported lot number.The evidence of that complaint confirm product met specification and was conductive.End of report.

Event Description

New information: it was reported that the patient was given two shocks using the same pads with two different defibrillators.

• Brand Name: 3M DEFIB PADS
• Type of Device: CONDUCTIVE GEL
• Manufacturer (Section D): 3M INFECTION PREVENTION; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: linda johnsen ; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 6896043
• MDR Text Key: 87439238
• Report Number: 2110898-2017-00131
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 30707387284740
• UDI-Public: 30707387284740
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2346N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 24 YR
• Patient Weight: 35