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

Model Number 22770PC

Device Problem Arcing of Electrodes (2289)

Patient Problem Burn(s) (1757)

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the defib pads arced, and the patient received a minor burn.This has been reported in medwatch.The patient did not require any treatment.

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
• 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: 18192205
• MDR Text Key: 328806838
• Report Number: 1219103-2023-00376
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20884527022394
• UDI-Public: 20884527022394
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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: 317401X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2023
• Type of Device Usage: A
• Patient Sequence Number: 1