MAUDE Adverse Event Report: CARDINAL HEALTH ADULT DEFIBRILLATION ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	2270PC
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Arc during cardioversion resulting in minor burn.

• Brand Name: ADULT DEFIBRILLATION ELECTRODES
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 18121414
• Report Number: MW5148034
• Device Sequence Number: 7715423
• Product Code: MKJ
• UDI-Device Identifier: 20192253017639
• UDI-Public: (01)20192253017639
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 11/07/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2025
• Device Catalogue Number: 2270PC
• Device Lot Number: 317401X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male