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 Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
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.

• 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): MA028 MA-CHICOPEE; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25526736
• Report Number: 1423537-2026-00196
• Device Sequence Number: 10762786
• 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
• 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
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 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