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

Model Number 22550A

Device Problem Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 324243395
• Report Number: 1219103-2023-00372
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20192253017547
• UDI-Public: 20192253017547
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1