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

Model Number	22770R
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the pads sparked during resuscitation and had to be removed from patient.Additional information received on 24apr2026 stated that there was no delay in care or impact to patient noted.They were able to continue acls code protocol without interruption.Patient did have a small 2-3inch mark on skin following event.Patient's skin was clean, dry, and intact and prepped properly prior to placement of pads and patient was not wearing jewelry at time of event.Unknown if oxygen was being used.Patient expired which was unrelated to the reported product or event.
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 ; 5082163840
• MDR Report Key: 25036697
• Report Number: 1423537-2026-00130
• Device Sequence Number: 13021583
• Product Code: MKJ
• UDI-Device Identifier: 20192253018889
• UDI-Public: (01)20192253018889(17)280202(10)604367X
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P190007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: 22770R
• Device Catalogue Number: 22770R-
• Device Lot Number: 604367X
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 158 KG
• Patient Race: Black Or African American