Summary of MedSun Reports Describing Problems With External Defibrillation and Multifunction Electrodes
MedSun: Newsletter #62, July 2011

External defibrillation and multifunction electrodes are single-use medical devices used in the emergency treatment of cardiac arrest patients. These devices are used in conjunction with compatible automatic external defibrillators (AED) or defibrillator monitors which can perform limited monitoring of a patient's ECG, delivery of defibrillation energy to a patient, and possible external pacing or cardioversion. (510(k) Summary, 2005), (510(k) Summary, 2007)

Over the past 2 years, MedSun has received 12 adverse event reports associated with the 8 devices manufactured by Kendal LTP, Philips Medical Systems, Physio-Control, and Zoll Medical. The reports were submitted by 9 hospitals between March 2009 and March 2011.

The reported device problems were:
• 2 Reports of electrode/pad not adhering to patient
• 1 Report of spark from electrode
• 1 Report of defibrillator electrode placed over ECG electrode
• 1 Report of a wire disconnection to electrode
• 1 Report of labeling of package: multifunction vs pacemaker only
• 1 Report of packaging/labeling: can not open package
• 5 Reports can not be determined from the event

The patient problems listed below were reported in 11 of these 12 reports.
• 6 Patient burns
• 3 Possible delay in treatment
• 1 Skin breakdown
• 1 Shock to caregiver
• 1 Cannot be determined from the event

Of the reports that listed patient age, none had a patient age listed as less than 21 years and 6 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 2 reports involved female patients and a total of 4 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

Photographs of patient burns, such as the ones described in some of the reports included in this summary appear below:

 Image shows 3 small burn marks on the patient’s trunk.  Burns are associated with electrodes having been placed on this area of the patient’s body.

 This is a close up of image of the same patient who received 3 small burns associated with electrodes having been placed on the patient’s body.


The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with External Defibrillation and Multifunction Electrodes
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Physio Control, Inc. Quik-Combo Edge System 3010188-011, 22517, N/A Patient burned by electrodes while connected to a Physio-Control defibrillator.
Zoll Medical Corporation One Step 8900-0214-01, 10312023, 8900-0214-01 Zoll defibrillator pads were utilized for temporary transcutaneous pacing from 15:20 hours to 19:30 hours. When the pads were removed at 09:50 on the next morning, three circle burns were noted on the patient's chest left of the sternum. The appearance of the circles was also noted on the Zoll pad. A dermatologic consultation/examination was performed on the same day the defibrillator electrodes were removed with the following conclusions: erosions, left inframammary chest. Given the well-defined appearance of these erosions this is suspicious for external-induced injury as well as char on the pacer pad, this may likely represent external injury/thermal injury due to the transcutaneous pacing. Physical examination: skin examination of the left inframammary chest revealed three small circinate well-defined erosions. There is no necrosis or gunmetal gray coloration to the lesions. Treatment will be topical with application of Vaseline to the wounds three times daily until healed. No sign of infection currently noted. The pad was saved. Manufacturer response for Electrode, Defibrillator, External, One Step: Pad was sent to the manufacturer
via mail. As of today, no response from manufacturer.
Kendall-LTP Cadence MediTrace 22770PC, 28106, N/A Our ICUs have continued to report problems with the Covidien Cadence MediTrace defib pads when placed for longer term use; since we began using this defib pad about a month ago, more than 10 events have been reported when these pads were placed in an emergency and quickly "lost contact" as the pad edges rolled off patient's skin, resulting in pads needing to be replaced before the next use. There have also been two reports of skin breakdown along the edges of the Covidien pad adhesive after these pads were removed. The maximum time these pads might be left in place by our protocol is 24 hours, however as noted we are receiving frequent reports that Covidien pads seem to fall off and lose contact in 2-3 hours. Health Professional's Impression: Two issues have been identified: 1) Covidien pads are insufficiently adherent in some cases. 2) Two issues of skin breakdown related to these pads. Manufacturer response for Electrode, Defibrillator, Multifunction, Cadence MediTrace: Ongoing discussion with field representative.
Meditrace, 1210H 31177721, N/A, N/A Patient was being cardioverted. Possible spark from anterior electrode on the patient's chest noted during cardioversion, by the physician and the CRNA in attendance. Also, a burning smell was reported at this time. The electrodes were removed and new ones were applied. The patient did not have any apparent burns on the chest. Health Professional's Impression: Defibrillator was checked by the biomedical engineering department and no abnormalities were identified. Per biomedical engineering, hair was noted on the actual electrodes which may have interfered with proper contact with the patient's skin.
Kendall-LTP, MediTrace Cadence N/A, 23215, 22770PC Covidien Cadence defib pads are not adhering as expected. Example 1: Defibrillator pads were placed at about 11 am during a code three hours later; the posterior pad was found buckled and rolled up on the patient's back. Pads had to be replaced prior to a needed cardioversion. Several episodes reported of similar events: Event #2: Pads were placed for monitoring and potential need for pacing for the patient in a complete heart block. A few hours later the edges of the pads were noted rolling off, both the anterior and posterior pads; original pads were replaced with new pads. We routinely change pads at 24 hours. At 24 hours, the edges of these pads were again rolling off. The problem appears to be that the outer white adhesive of the pad is not adhering well to the skin. Health Professional's Impression: Pad edges are not adherent enough.
Philips Medical Systems Adult Plus M3713A, N/A, N/A The patient was in ventricular fibrillation. One shock was delivered via hands free patches. A few minutes after the shock was delivered, the RN was shocked when chest compressions resumed and her hands touched the defibrillation electrode pad. The EKG clip was noted to be touching the defibrillation electrode pad.
Physio-Control Inc. Quik Combo N/A, 935802, 11996-000091 Patient was in surgery, near end of a repeat CABG operation with defibrillator electrode pads placed on the left and right sides. Patient began ventricular fibrillation, and defibrillation was attempted via the external pads 5-6 times at 200 Joule setting. Then several attempts were made using internal defibrillator paddles, which succeeded. While attempting to close the patient's chest, v-fib occurred again and several more defibrillator attempts were made using the external pads and a 360 Joule setting, until the defibrillator alarmed that the pads were not securely connected. Inspection revealed that the leadwire had separated from the left-side pad. Under the wire was a blister 5 cm long on the patient's left flank near the arm pit, with a charred region around the blister. The electrode pads were replaced with a new set. After a few more defibrillation attempts, the patient recovered, then was sent from the OR to the critical care unit where the blistered area was treated with an appropriate dressing. Patient was eventually discharged to home. The skin injury was granulating by that time and the patient's instructions were to continue keeping the area covered with a dressing. Health Professional's Impression: The broken or separated electrode wire was attributed to mechanical stresses from the patient's severe muscle contractions during repeated defibrillation attempts. Manufacturer response for Electrode, Defibrillator Pads, Quik Combo: Mfr stated that Quik Combo pads should be replaced after 25 discharges, and was unaware of problems with our lot number.
Zoll Medical Corporation Stat Padz 8900-4003, N/A, N/A It was discovered that a patient had a minor burn after pacer pads were removed. The patient had been on an external pacer for about 24 hours and when the pacer pad was removed it was discovered that an ECG electrode, from a previous 12 lead ECG, had been left on the patient underneath the pacer pad. The burn was discovered in ICU but the pacer pads were placed in the Emergency Department. It is believed that the burn was caused by the electrode that was left on the patient unintentionally. We do not feel that the Zoll product was defective but are reporting this so others can be aware of the potential for harm. The electrode left on the patient unintentionally caused the burn.
Zoll Medical Corporation Pro-Padz N/A, 5209, 8900-4005 This lot number of pads had 4 incidents of pad burns in the EP lab. The burns were first degree with skin peel around the edge of burned area. All 4 patients had intact skin anterior and posterior prior to chest pad placement. There was no skin prep prior to placing the pads. The burns followed 2-4 defibrillations at 150 joules. Silvadene cream was applied to all burn sites. Health Professional's Impression: No problems have occurred with any other lot numbers. Manufacturer response for defibrillator adult pads, Translucent: The remaining pads from the same lot number were returned to tech support. No other problems have occurred since this lot was pulled. No answer from manufacturer yet.
Zoll Medical Corporation Pro-Padz 8900-4005, N/A, N/A The patient was cardioverted X 3. #1. 120 joules 155.5 delivered, #2 120 joules selected 158.4 delivered, 3rd shock 200 joules selected 299.8 delivered. On the first and second shocks, the physician stated he heard a "popping sound". On the third shock he looked at patient's head and saw a "ball of fire" come out of the patient's mouth. Superficial first degree burns were noted around the rim of the anterior Zoll pad about 3 to 5 cm in length. Sivadene ointment was applied. There was no evidence of harm to mouth area. No excess metal in mouth although patient did have metal rod teeth implants. The patient had a concave chest and entire chest and arms were tattooed. The circular Zoll pad is rigid and did have to be pressed in place to adhere to the skin. The patient was successfully cardioverted and was discharged without any further problems.
ZOLL Medical Corporation Pedi-Padz N/A, 4309 and 5009, 8900-1065 and 8900-2065 During a patient event a Zoll defibrillator was being prepped for standby. Staff needed a MULTI-FUNCTION electrode pack but inadvertently pulled a PACING ONLY electrode pack from stock. If the defibrillator had been needed and staff had not recognized the mistake by trying to plug the pad into the cable there could have been potential for patient harm. The two electrode packs look very similar with the only difference being the MULTI-FUNCTION label is tourquoise on one pack and the PACING ONLY label on the other is green. A more visible difference in the color of the two packs would have been an earlier indication of which electrode pack was needed. We were using the "multi-function cable" with the defibrillator which would require the "multi-function electrode cable" to work. Zoll makes a "pacing only cable" that is used with the "pacing only" electrode pack. The two (the multi-function and pacing only) cables are not interchangeable but similarly labeled
Covidien Kendall Medi-Trace Cadence Pre-Connect RTS 22770PC, 907226, N/A The nurse opened the outer plastic package of defibrillator/pacing electrodes. She was unable to open the inner package. Scissors were used to open the package. The nurse had to cut around the machine cable that protrudes from the inner package. No patient adverse event resulted. The package is stored in temperature controlled storage rooms maintained at normal room temperature. Biomed took an unopened package and opened it. The same problem was encountered and there was difficulty getting the electrodes out of the package. However, another biomed from another facility attempted to open the package. He intuitively opened the package correctly. He just tore the tab all the way across the package despite the cable protruding through the tab. We believe that this is poorly designed packaging that should be changed and the manufacturer should emphasize proper instructions for opening the packaging. Manufacturer response (as per reporter) for pacer defibrillation pad (Pre-connect), Medi-Trace Cadence PC Manufacturer requested defective product to be returned. Since that product had already been discarded, we are sending sample of what is believed to be the same lot number.

Additional Information:

(2005). 510(k) Summary. Retrieved from

http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051076.pdf

(2007). 510(k) Summary. Retrieved from

http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072812.pdf


MedSun Newsletters are available at www.fda.gov/cdrh/medsun