MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MEDI-TRACE CADENCE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	22770R
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented to the cardiac cath lab for a cardioversion.Patient was noted to have hair on the chest that was removed using clippers prior to pad placement.The pads were placed on a clean, dry chest.When the charge was delivered, there was a bright spark and burning odor.When the pads were removed, a burn mark was noted in the middle of the patient's chest.

• Brand Name: MEDI-TRACE CADENCE
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 25762612
• Report Number: 25762612
• Device Sequence Number: 21450456
• Product Code: MKJ
• UDI-Device Identifier: 20192253018889
• UDI-Public: (01)20192253018889
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/01/2026
• Report Date (Section F): 07/01/2026

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 Model Number: 22770R
• Device Catalogue Number: 22770R-
• Device Lot Number: 609390X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2026