MAUDE Adverse Event Report: CARDINAL HEALTH MEDI-TRACE# CADENCE ADULT RTS ZOLL; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 22770R

Device Problem Arcing of Electrodes (2289)

Patient Problem Burn(s) (1757)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The customer reported on (b)(6) 2023, a patient was having an ep ablation performed and needed to be cardioverted.One of the technicians heard a "pop" when the shock was delivered.They then smelled a burning odor.After examining the patient, they observed a 1st degree burn on the left lateral chest and a 2nd degree burn on the left upper chest.There was a skin fold close by, but the electrode was firmly affixed.There was no prep applied prior to placement.There were 200 joules administered during the cardioversion.The patient was treated with topical silvadene cream.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed showing no abnormal process conditions present during the manufacturing of the product, or the subassemblies that could have led to the reported condition.Three photos were returned for evaluation.The first photo is of the pouch.The second photo is of the back/foam side of the electrode pad set.Reviewing the photo shows there is no indication of damage to the foam side of the product.The third photo is of the gel side of the electrode set.This photo shows what appears to be soot in three areas of one of the gel body pads.Both pads show hair scattered throughout the gel area, and some on the foam adhesive area.The arc of shock in the presence of a high concentration of oxygen with nearby combustible material such as hair and fabric fibers can result in patient burns.From a root cause perspective, it is important to note that these electrodes provide a reduced skin irritation (burns), but do not eliminate skin irritations.Erythema¿s, burns, and even blisters while not desirable, are not an uncommon consequence of defibrillation/cardioversion.Care should be taken to properly prepare the patient skin prior to electrode application.With no physical sample to inspect, 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.We will continue to trend for future occurrences as part of the complaint review process.

• Brand Name: MEDI-TRACE# CADENCE ADULT RTS ZOLL
• 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: 18011539
• MDR Text Key: 326617264
• Report Number: 1219103-2023-00374
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20192253018889
• UDI-Public: 20192253018889
• 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: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 22770R
• Device Catalogue Number: 22770R
• Device Lot Number: 323743X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1