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

Model Number	N/A
Medical Device Problem Codes	Failure to Conduct (1114); Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Sudden Cardiac Death (2510)
Date of Event	08/24/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
No title of the initial reporter was provided.This complaint is linked to 2110898-2017-00131.Since a different product was used and replaced the product used under this complaint.Product has been shipped to 3m for evaluation but not received yet for evaluation.It was noted the pads looked normal and were wet.End of report.
Event or Problem 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 initial defibrillation nor a response from the patient.The 3m defib pads were removed and replaced with new set and different catalog number.Patient subsequently died.It was confirmed the defibrillator used with these specific defibs pads worked according to the manufacturer's specifications.
Additional Manufacturer Narrative
The following information was not included in the initial report.A statement from the biomedical engineer of the hospital indicates testing was conducted on all items and worked in the correct way.The method biomedical engineer used to evaluate the defib pads was not specifically stated.The assumption is the testing was a visual for wetness.However, all production data from lot 2018-11au applies to model 2345n was reviewed.All production data was normal and there were no ncns for issues recorded during the run of this lot.All release testing of this lot passed all specifications.Data from the coating step of this lot was reviewed as well, and all data was within specification with no recorded nonconformances.A total of six retains samples were examined from lot 2018-11au.All 6 retains were tested for impedance and all 6 samples were within specification.End of report.
Event or Problem Description
Additional information: application of a first set of patches (2345n) was placed onto the patient and two external shocks using the same defibrillator was give to the patient.No sign of conduction.Another set of pads were applied using a different model number.

• Brand Name: 3M DEFIB PADS
• Common Device Name: CONDUCTIVE GEL
• Manufacturer (Section D): 3M INFECTION PREVENTION; 2510 conway avenue; st. paul MN 55144
• MDR Report Key: 6896056
• Report Number: 2110898-2017-00130
• Device Sequence Number: 16348614
• Product Code: GYB
• UDI-Device Identifier: 30707387284733
• UDI-Public: 30707387284733
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 2345N
• Device Lot Number: 2018-11 AU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 24 YR
• Patient Weight: 35