MAUDE Adverse Event Report: CONMED CORPORATION PADPRO:DEFIB PADS:MEDTRONIC; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	2001M-C
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility returned two original samples to conmed for evaluation.Although the samples were received with opened original packaging, they were not associated with the packaging or a lot number; therefore, they were both evaluated.The first set of used pads was received folded together.Visual inspection found the cord cut off.The pads were dissected and the fanned carbon wires were misaligned on both the anterior and posterior pads.Visual inspection of the second set of used pads found a cut in the back foam of the anterior pad; it is unknown when this cut to the pad occurred.The pads were dissected and not abnormalities were found.In addition to the original samples, twenty two lot samples were received for evaluation of which a sample of eight were visually inspected and functionally tested.Dissection of two of the samples found fanned carbon wires that were misaligned with the edge of the conductive square on one of the pads.No abnormalities were found on the third sample.A two-year review of complaint history revealed a total of 6 similar complaint, with 8 devices, for this device family and failure mode combination.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent, if all complaints were confirmed.Per the instructions for use, the user is advised the following: - no modifications of this device are allowed.- misuse of multifunction electrodes, use of compromised or altered product, and/or failure to follow product instructions may result in patient burns, inadequate delivery of therapy, and/or loss of ecg trace quality.- make sure skin is dry and free of sweat, water, alcohol, etc.- do not use if packaging seems compromised.- do not fold, trim, crush, or store under heavy objects.- misuse of electrodes may cause patient burns.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed representative reported on behalf of the user facility that during a cardioversion with 2001m-c pad, a spark was witnessed where the wire entered the pad.The pad involved was the anterior pad placed on the patient's midsternum.The cardioversion was successfully completed with no additional interventions required.No patient injury or surgical delays was reported.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: PADPRO:DEFIB PADS:MEDTRONIC
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7655064
• Report Number: 1320894-2018-00156
• Device Sequence Number: 1651883
• Product Code: MKJ
• UDI-Device Identifier: 10653405042587
• UDI-Public: (01)10653405042587(17)210327(10Y03271809
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K014209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 2001M-C
• Device Catalogue Number: 2001M-C
• Device Lot Number: Y03271809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/02/2018
• 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: Other
• Patient Age: 81 YR
• Patient Weight: 80