MAUDE Adverse Event Report: CARDINAL HEALTH ELECTRODE ADULT 4.5X6.25 DEFIBRILATION; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	22550A
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/28/2023
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 during a direct current cardioversion to treat an atrial flutter there was a spark on the anterior left chest pad.The patient converted to sinus rhythm after 1 shock at 250 joules and the pad was removed from the patient's chest.Two thermal burns approximately 1/2"x2" were found.The patient received superficial (first degree) burns.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product, or the subassemblies that could have led to the reported condition.No samples have been received.Without samples it is not possible to determine root causes or to determine if they could be manufacturing related.No corrective or preventative actions will be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: ELECTRODE ADULT 4.5X6.25 DEFIBRILATION
• 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: 17816895
• Report Number: 1219103-2023-00372
• Device Sequence Number: 14063567
• Product Code: MKJ
• UDI-Device Identifier: 20192253017547
• UDI-Public: 20192253017547
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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: 22550A
• Device Catalogue Number: 22550A
• Device Lot Number: 313079X
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown