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 Code	Superficial (First Degree) Burn (2685)
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,physiocontrolquikcombodevice was being used on an unknown date during a hemodynamics procedure when it was reported ¿burn occurs immediately after the first shock.¿.Further assessment found that the patient experienced a 1st degree burn and it was treated with trolamine located on the anterior chest.The procedure was completed and there was no report of surgical intervention or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
G3 initial awareness date was 02jun26 the device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.

• 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: 25649934
• Report Number: 1320894-2026-00164
• Device Sequence Number: 5877833
• Product Code: MKJ
• UDI-Device Identifier: 10653405042570
• UDI-Public: (01)10653405042570(17)280225(10)Y02252502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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
• Device Catalogue Number: 2001M
• Device Lot Number: Y02252502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown