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

Model Number	22550R
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after cardioverting a patient, the staff/physician noticed a visible spark coming from the pads, smell of smoke, and patient had a burn on their skin in the shape of one of the black inner-ring corners.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.

• 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
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25526679
• Report Number: 1423537-2026-00191
• Device Sequence Number: 10741466
• Product Code: MKJ
• UDI-Device Identifier: 20192253017585
• UDI-Public: (01)20192253017585
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2026

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: 22550R
• Device Catalogue Number: 22550R-
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 06/30/2026; 07/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown