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

Model Number 22550R

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

The customer reported there is an erythema where the electrode has been placed.Additional information received stated when the shock is applied during electrical cardioversion, sparks jump in the anterior electrode, producing a skin burn that will require follow-up and treatment in primary care.The customer has observed this in the different cardiology departments since using the medi-trace patch.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information received stated the burns required treatment with silvederma and/or atrauman.It is unknown if both ointments were used for the patient.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Quality assurance testing included an array of electrical tests.During production of the finished electrode there are two different steps whereby the connector is plugged into a receptacle that would reject any molding defects that would impair the connection.As part of the final assembly process of the defib electrode, each defib wire set is tested for continuity to ensure that the connector assembly can conduct current, and that it demonstrates electrical continuity.Should this continuity test fail, the product would be discarded.Finished goods wire testing is performed to ensure the finished product is working correctly.Lastly, prior to packaging the final defib electrode assembly, the product is 100% visually inspected.No samples were returned, however, retain samples were reviewed.There were no abnormalities observed with the wires and gel body of the retained samples.From a root cause analysis perspective, it is important to note that these electrodes provide a reduced skin irritation, but do not eliminate skin irritation.Erythema¿s, burns, and even blisters while not desirable, are not an uncommon consequence of defibrillation/cardioversion.Defibrillation/cardioversion requires high intensity electrical energy to be delivered to the body through the skin, which generates heat at the contact site.Repeated shocks of escalating energy, often required for a successful defibrillation/cardioversion, will exacerbate the undesirable side effects of therapy.It should be noted that conductive printed gradient design reduces the probability and extent of irritation resulting from defibrillation, but it does not eliminate it.It is important to read, understand and follow the care instructions included with the product.Care should be taken to properly prepare the patient's skin prior to electrode application.Failure to comply with the product instructions for use or warnings may increase the likelihood of a patient exhibiting skin irritation.All materials have been deemed safe and effective for use per the iso standards.The results of the manufacturing facility investigation were unable to attribute any potential root causes associated with the manufacture of product which would have contributed to the burns.Based upon the investigative details and the root cause evaluation, no corrective or preventative actions are required to be taken at this time in relation to the customer described event.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.

• 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: 14788903
• MDR Text Key: 303179734
• Report Number: 1219103-2022-00358
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20192253017585
• UDI-Public: 20192253017585
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 203830X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2022
• Type of Device Usage: A
• Patient Sequence Number: 1