MAUDE Adverse Event Report: CONMED CORPORATION RADIOTRANSPARENT ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	2001 PADPRO
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent cardioversion procedure.After defibrillator was used, there was a strong odor of something burning.Defibrillator and pads were immediately removed from patient.Unsure if odor was from defibrillator or pads used on back.Fda safety report id # (b)(4).

• Brand Name: RADIOTRANSPARENT ELECTRODES
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 11462439
• Report Number: MW5099924
• Device Sequence Number: 17112925
• Product Code: MKJ
• UDI-Device Identifier: 10653405004714
• UDI-Public: (01)10653405004714(17)231109(10)
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: 11/09/2023
• Device Model Number: 2001 PADPRO
• Device Lot Number: Y11092004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1