MAUDE Adverse Event Report: COVIDIEN CADENCE PHYSIO QC ADULT RTS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22550R

Device Problem Arcing of Electrodes (2289)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the defib pads arced and the gel melted off while being used.There was no harm to the patient.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.All process parameters, product, raw materials, and sub-assembly components met the required acceptance criteria to completely satisfy the manufacturing requirements per the product specification.No adverse conditions, special circumstances, or events were documented.One sample was received at the plant for evaluation.The electrode pouch was also provided.The label on the pouch indicated the lot number to be 824256x.The two electrodes were stuck to each other (one pad stuck to the backside/foam side of the other electrode).Upon a visual inspection of the electrode pad set a portion of the gel was found to be missing/lifted or as described by the customer ¿melted¿ from substrate across the center of one of the electrode pads.The other pad was carefully lifted from the back side to expose the gel.The gel appeared to be intact across the pad (could not completely remove without damaging electrode for further evaluation).What the customer experienced may have been delamination of the gel from the substrate when removed from the carrier liner, however they did not note this prior to placing on the patient.The delamination on the returned sample did extend into the silver printed area on the electrode sets, and the delamination did include the conductive mat area.The degree of delamination on the electrode pad was evaluated as part of the investigation.The degree of gel separation/ delamination was determined be approximately 20% (80% of gel remained intact).The gel delamination was within 22% maximum hydrogel separation (when the conductive mat is included) from the adult electrode criteria.Gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.Such an inequity in bond strength can cause the gel to peel from the substrate and/or tear.This would have occurred prior to being placed on the patient.Per the customer statement the gel melted off while in use, however as previously stated they may have not noticed prior to placing on the patient.Delamination is categorized as follows: an aesthetic delamination defect is characterized by a permanent separation of the hydrogel from the substrate, exposing the underlying carbon vinyl with little (i.E.Area less than 1/8-inch x 1/8-inch) or no hydrogel remains on the release liner.Also, no silver/silver chloride ink is exposed.Aesthetic delamination defects will not significantly affect electrode function but may displease the clinician.Functional delamination is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.Additionally, there shall be no less than 78% hydrogel remaining on the adult electrode, when the area of separation includes the area of underlying conductive mat.With loss of the hydrogel no more than the percentages as defined above the electrodes retain functionally essential performance; however, the reduction in the hydrogel area with the silver/silver chloride ink being exposed may cause an increase in current density across the remaining gel area.This increases the potential for skin irritation and burns.As part of continuous improvements, the plant has recently approved the use of an improved uv curing system.The variable power output of the uv fusion system allows more flexibility to dial in the uv intensity while mitigating excess heat generation in the oven and improving single directional peel (delamination) performance throughout the life of the product.This complaint will be used for qa tracking and trending purposes.

• Brand Name: CADENCE PHYSIO QC ADULT RTS
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 8347116
• MDR Text Key: 136608600
• Report Number: 1219103-2019-00224
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/23/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 824256X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/11/2019
• Patient Sequence Number: 1