MAUDE Adverse Event Report: CONMED CORPORATION DYNATRACE ELECTRODE; FOAM/WET GEL ELECTRODE

Catalog Number 1500-004

Device Problem Insufficient Information (3190)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

The reported device is catalog number 1500-004, a conmed dynatrace foam wet gel ecg electrode made with 10% chloride gel and a polyethylene foam base pad.Both materials are tested for cytotoxicity, sensitization, and intracutaneous factor per iso approved testing [bt-1001 (p), ecg electrodes tf-01].The product is marketed as a mri safe electrode.It is manufactured with a one-piece plastic stud which is designed to not significantly be influenced by a mri scan.As of this filing, the "used" electrodes have not yet been returned from the user facility for evaluation.In addition, no visual evidences (photographs) of the patient injury or devices were provided by the end-user.Without the involved devices, an evaluation could not be performed and the root cause of the alleged "burns" therefore could not be determined.Based on the provided lot #1411211, the involved device was manufactured on 21-nov-2014.A review of the device history record for this lot found no noted discrepancies during the manufacturing process.Of the lot containing (b)(4) devices, there were no other similar reports received other than (b)(4) reported complaints from this user facility.A 2-year review of the device family complaint history showed a total of (b)(4) complaints including (b)(4)received complaints for "burn" to patient.During this same 2-year time frame, over (b)(4).It should also be noted, of the (b)(4) reported incidents, there have been only (b)(4) cases related to 2nd degree burns in the past two years.An electrocardiograph electrode is an electrical conductor which is applied to the surface of a body to transfer the electrical signal at the body surface to a processor via lead wires and cables that produce an electrocardiogram to be used by the clinician in diagnosing or monitoring a patient's condition.These electrodes are single use, disposable devices that are intended to be used by experienced and trained medical personnel in hospitals, clinics, physician offices and pre-hospital environments.General purpose monitoring electrodes may typically be used for up to 5 days.Duration of use may vary depending upon skin condition and environmental factors.Conmed's ecg electrode products have been tested as mri safe in a testing performed by an independent contractor, dr.(b)(4).The main objectives of this mri safety testing were to determine the presence of magnetic field interactions, artifacts, and, heating for these devices in association with the use of an mri system.These tests were performed using a 1.5 tesla mri system (general electric co., signa system); therefore, results of the tests that were conducted are applicable to all mri systems with static magnetic field strengths of 1.5 tesla or less.The heating of the ecg electrodes during mri was determined by performing an extreme mri experiment with the ecg electrodes applied to a human subject.Temperature recordings were obtained in this experiment using a luxtron 3100 fluoroptic thermometry system previously demonstrated to be mri-compatible and unperturbed at static magnetic field strengths up to 9.0 tesla.This thermometry system has fiber-optic probes that have an accuracy and resolution of +/-0.1degree c.A fiber-optic probe was placed between the volunteer subject's skin and ecg electrode undersurface to record temperatures during mri.Baseline temperatures were recorded at one minute intervals for 5 minutes.Mri was then performed for 30 minutes, with temperatures being recorded at one minute intervals.The highest temperature changes measured for the ecg electrodes ranged from +0.2 to +0.5 degrees c (+0.2 to +0.4 degrees c for tested conmed products).This relative amount of heating is physiologically inconsequential and will not create a hazard or risk to a patient utilizing one of the ecg electrodes tested, and, undergoing an mri procedure under the conditions of the experiment.In summary, it was concluded that there should be no risks to patients undergoing mri procedures using mri systems operating at 1.5 tesla or less when utilizing any of the tested ecg electrodes.It should be noted that on the united states fda (food and drug administration) website it points out that, even though you may be using electrodes and cables that are approved for use during an mri, a serious burn can still develop if the electrodes aren't in complete contact with the skin surface (that is, if excess hair hasn't been removed or there's an air gap between the electrode and the skin).When there's an air gap, the electrical pathway is broken and heat can build up at the center of the electrode as well as letting the current arc from the electrode to the skin, which can cause burns.Don't let the cables form a loop and keep them off the patient's skin by placing a blanket under them.Http://www.Fda.Gov/cdrh/devicaldevicesafety/tipsarticles/electrodes.Html it is not known if the ecg monitor cables utilized by the end-user facility were mri compatible.Heat produced by a cable that is not tested as safe to use during a mri could be transferred to the patient through an mri safe ecg electrode and result in a patient burn.The ifu states: "the electrode site should be dry before electrode application.Fluids, including skin cleansing solutions, lotions or soapy water may cause skin irritation and loss of adhesion.Keep electrode site dry".It also states "rapid removal of the electrode from the patient may cause skin damage.If the electrode is difficult to remove, use alcohol on long term electrodes to moisten the adhesive-skin interface.The use of water will facilitate the removal of repositionable electrodes".The complaint devices were not returned by the end-user facility.The complaint investigation has not identified or confirmed any manufacturing defects associated with the suspected device therefore, no further action is planned at this time.

Event Description

The user facility reported that over the past three months, five (5) different patients have experienced a significant burn where the conmed dynatrace adult electrodes were placed.In three (3) instances, the reporting facility alleged that patients sustained the burn to their upper extremity where the electrodes had been placed.In two (2) other instances, the alleged burn was on the patient's abdomen.Of the five (5) alleged incidents, two (2) patients reportedly received second degree burn (see mdr #1320894-2015-00028).No postoperative medical treatment information was provided on either alleged 2nd degree burn.The involved electrodes were not returned to conmed for evaluation and photos of the alleged burns were not provided from the user facility.To date, no responses received from the user facility despite numerous attempts made to obtain further information surrounding these reported incidents along with patient demographics information, etc.

• Brand Name: DYNATRACE ELECTRODE
• Type of Device: FOAM/WET GEL ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: vickie ingle ; 525 french rd; utica, NY 13502 ; 3156243053
• MDR Report Key: 5165983
• MDR Text Key: 28905950
• Report Number: 1320894-2015-00027
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/21/2016
• Device Catalogue Number: 1500-004
• Device Lot Number: 1411211
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Other