MAUDE Adverse Event Report: Cardinal Health 200, LLC Medi-Trace Cadence; Automated External Defibrillators (Non-Wearable)

Model Number	22770R
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction

• 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 ; +1(508)316-3640
• MDR Report Key: 50058359
• Report Number: 1423537-2026-00245
• Device Sequence Number: 13098683
• Product Code: MKJ
• UDI-Device Identifier: 20192253018889
• UDI-Public: (01)20192253018889(17)280309(10)609390X
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P190007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 609390X
• 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: 07/09/2026
• Initial Report FDA Received Date: 07/28/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown