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

Model Number	2001Z-C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After anesthesia provided sedation; 200 j of synchronized energy used, and a small pop occurred at the site of the pad.So, we changed the pads and repeated the cardioversion with 200 j and pressure, and patient converted to sinus rhythm.The pads were removed there does not appear to be any burn marks.

• Brand Name: PADPRO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 23862775
• Report Number: 23862775
• Device Sequence Number: 13086270
• Product Code: MKJ
• UDI-Device Identifier: 10653405042488
• UDI-Public: (01)10653405042488(17)280425(10)Y04252501
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025
• Report Date (Section F): 12/03/2025

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 Model Number: 2001Z-C
• Device Catalogue Number: 2001Z-C
• Device Lot Number: Y04252501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/03/2025