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

Catalog Number	2001M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the 2001m adult/child=10kg radiotrans electrd,physiocontrolquikcombo device was being used during a hemodynamics procedure on (b)(6) 26 when it was reported ¿the application of shock in synchronized cardioversions, with maximum energy of 360 j, in af, leaves burns on the patient¿s chest (the outer edge).It is necessary to confirm the characteristics and gel of the electrodes.¿.Further assessment was attempted, and a good faith effort was completed with no information found.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due patient obtaining an unknown degree of burn.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.H3 other text : device not yet received.

• Brand Name: PADPRO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): KATECHO, INC.; 4020 gannett ave; des moines IA 50321
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 24740549
• Report Number: 1320894-2026-00073
• Device Sequence Number: 18704335
• Product Code: MKJ
• UDI-Device Identifier: 10653405042570
• UDI-Public: (01)10653405042570(17)280225(10)Y02252502
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2001M
• Device Lot Number: Y02252502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 06/24/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/14/2026; 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic