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	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G3 initial awareness date was 02jun26.The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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.
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 (b)(6) 2026 during a hemodynamics procedure when it was reported "another incident happened with the same batch of padpro units, a burn occurs immediately after the first shock at 200 j.Additionally, a different defibrillator was used and the issue still occurred." further assessment found that the patient experienced a 2nd degree burn and it was treated with grade 2 dressing with greasy gauze 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 on the reported injury due to the patient experiencing a 2nd degree burn.

• 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: 25649880
• Report Number: 1320894-2026-00163
• Device Sequence Number: 21269769
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown