MAUDE Adverse Event Report: CARDINAL HEALTH CADENCE PHYSIO QC ADULT RTS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 22550R

Device Problem Arcing of Electrodes (2289)

Patient Problem Burn(s) (1757)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

The customer reported that during the planned electrical cardioversion of the patient with atrial fibrillation, an audible bang occurred when a current of 360 j was delivered, followed by a burnt smell and burning of the skin on the left side of the patient.Per customer, from a surgical point of view, a slight burn.The burn on the patient¿s skin had an elongated curved shape, similar to a boomerang.Additional information was received and stated that there was a bang and a smell of burning noticed with the defib pads.It was unknown, if there was any medical intervention or treatment provided for the skin burn.

Manufacturer Narrative

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

Manufacturer Narrative

Section d1 / d2 (brand name): originally reported as cadence physio preconnect and should be cadence physio qc adult rts.Section d4 (model number and catalog number): originally reported as 22550pc and should be 22550r, (unique identifier (udi) #): originally reported as (b)(4) and should be (b)(4).

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured between (b)(6) 22 and (b)(6) 22.Three electrode sets were received for the analysis.One used set, where the electrode pads were stuck together, gel to gel and the other two were sealed unopened pouches.Electrical testing was performed for the used set and one of the unused sealed sets.Testing showed both sets performed well with electrical values within the acceptable range.During the testing the quality technician watched the sets to see if there were any issued during the shocking or any other part and no issues were observed.Visual inspection of all the sets did not show any issues or anomalies which could have contributed to the reported issue.Therefore, the reported issue was not confirmed.It is important that full engagement of the electrodes to the body of the patient to ensure the current density is distributed over the intended surface area of contact.A reduced area of engagement to the body would result in a higher current density in a smaller area.Potential ramifications of such a situation could involve thermal effects (e.G.2nd or 3rd degree burns on skin underlying the electrode).It is important to note that erythema, 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.Different defibrillators can deliver different levels of electricity through the electrode pads.Monophasic defibrillators supply higher electricity to the pads which could result in skin irritation/burns.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.Care should be taken to properly prepare the patient skin prior to electrode application and special consideration should be given to the electrodes and wires while working around a patient or moving a patient so that the electrodes are not damaged.To help the electrode make good skin contact and to help reduce contact impedance the product labeling instructions and warnings should be followed: remove excess hair.Clean and dry skin sites.Do not use alcohol or tincture of benzoin.Position electrodes per the figures provided on the packaging.If possible, do not place electrodes on broken skin.Smooth the electrode from the center outward to the edges with fingertips to ensure that there are no air pockets between the gel and the patient's skin.Electrodes are not repositionable.Replace with new electrodes if repositioning is required.This will ensure optimal adhesion and minimize potential patient skin burns.Remove the electrodes from the patient by slowly peeling pad from the patient¿s skin.Do not discharge hand-held paddles through these electrodes.Do not open package until immediately prior to use.Do not use if electrode or pouch is damaged.Based on the results of the investigation, we were unable to attribute any potential root causes associated with the manufacture of product which would have contributed to increased susceptibility of the reported issue.At this time, a corrective and preventive action is not deemed necessary.This complaint will be used for qa tracking and trending purposes.

• Brand Name: CADENCE PHYSIO QC ADULT RTS
• 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: 16704071
• MDR Text Key: 312912912
• Report Number: 1219103-2023-00370
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20192253017585
• UDI-Public: 20192253017585
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• 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: 215921X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 80 KG