MAUDE Adverse Event Report: COVIDIEN ELECTRODE ADULT 4.5X6.25 DEFIBRILATION; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22550A

Device Problem Gel Leak (1267)

Patient Problem Burn(s) (1757)

Event Date 01/01/1980

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/10/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer states the skin of a patient was burnt a little at the end of the electrodes (on the black line).The customer provide a samples without gel on the hole contour for evaluation.There was no gel on the whole turn of the electrode, but there was gel on the silver gradient (black contour).

Manufacturer Narrative

No lot or serial number was provided.A review of the device history report (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are in place to prevent nonconforming product in the manufacturing process.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Additionally, production retain electrode sets could not be revaluated due to the unknown lot number.The customer provided a sample without gel on the whole contour for evaluation.There was no gel on the whole contour of the electrode, but there was gel on the silver gradient (black contour).No additional information, pictures or videos were received pertaining to the reported condition.Therefore, a comprehensive investigation was unable to be conducted.As a result, an evaluation could not performed to determine if the burn (skin irritation) was typical of what a patient might experience using a defibrillation electrode product in a defibrillation procedure.It is important to note that these electrodes provide a reduced skin irritation, but do not eliminate skin irritation.Erythemas, 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.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.Important: replace the electrode pads after 24 hours on skin or 50 defibrillation shocks.Use separate ecg electrodes when performing noninvasive pacing.It is important that the operator be thoroughly familiar with the electrode operating instructions and warnings prior to use.Failure to comply with the product instructions for use or warnings may increase the likelihood of a patient exhibiting skin irritation.Another potential root cause is patient skin sensitivity to the gel or adhesive foam component of the electrode.Biocompatibility studies are performed on the adhesive foam and gels according to the guidelines defined in the iso standards.Each gel and electrode manufactured in the facility must pass cytotoxicity, primary skin irritation and skin sensitization testing before it is distributed for commercial sale.Each hydrogel offered for sale have passed all three tests to ensure the highest quality medical hydrogels available.In addition, all hydrogels manufactured as this facility must comply with iso standards.Skin reaction such as those experienced by the patient could be the result of an acute sensitization response to the material components that make up the electrode.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 susceptibility of skin irritation.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: ELECTRODE ADULT 4.5X6.25 DEFIBRILATION
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 7859766
• MDR Text Key: 119663810
• Report Number: 1219103-2018-00203
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22550A
• Device Catalogue Number: 22550A
• Date Manufacturer Received: 08/24/2018
• Patient Sequence Number: 1