MAUDE Adverse Event Report: CARDINAL HEALTH CADENCE ZOLL PRECONNECT; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	22770PC
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the defib pads arced, and the patient received a minor burn.This has been reported in medwatch.The patient was treated with polysporin and 2x2.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing no abnormal process conditions were present during the manufacturing of the product, or the subassemblies that could have led to the reported condition.There were no samples received with this case.The results of the manufacturing facility investigation were unable to attribute any potential root causes associated with the manufacture of product.Based upon the investigative details and the root cause evaluation, no corrective or preventative actions will be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: CADENCE ZOLL PRECONNECT
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18192031
• Report Number: 1219103-2023-00375
• Device Sequence Number: 7321506
• Product Code: MKJ
• UDI-Device Identifier: 20884527022394
• UDI-Public: 20884527022394
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 01/03/2024

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: 22770PC
• Device Catalogue Number: 22770PC
• Device Lot Number: 233575X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/03/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown