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

Model Number 22550R

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2021

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.

Event Description

The customer reported that a nurse placed electrodes on patient.When the defib was used, the electrode burnt the patient in a u shaped burn pattern.The nurse stated he actually saw a flash of sparks come from the electrode area while shocking the patient.Additional information received on 13-aug-2021 states that a cardioversion was being performed with a medtronic lifepack 20e.The instructions for skin prep were followed properly.The area of pad placement was free of hair and dry.The pads were placed flush on the skin and were in place for 20 minutes prior to delivering one shock at 360 joules.The first degree (superficial) burn was under the anterior pad only.It was approximately 1-1.5 cm from the edge of the pad and did not require treatment.Nasal prongs were in use on the patient during the incident.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described by the customer.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Quality assurance testing, performed based on a c=0 aql level, included an array of electrical tests; dc offset voltage, ac small signal impedance, defibrillation recovery, noise, large signal impedance, simulated defib recovery, pacing impedance, pacing offset voltage, wave form duration and pacing energy loss were performed.During production of the finished electrode there are two different steps whereby the connector is plug into a receptacle (replicates plugging into therapy cord) that would cull out (reject the connector plug) any molding defects that would impair the connection.As part of the final assembly process of the defib electrode each defib wire set is tested for continuity to ensure that the connector assembly can conduct current, and that it demonstrates electrical continuity.Should this continuity test fail the product would be discarded.Fgwt (finished goods wire testing) is performed to ensure the finished product is working correctly.Lastly, prior to packaging the final defib electrode assembly the product is 100% visually inspected.For lot 105000x (b)(4) sets were made between 01/26/21 and 01/28/21.Three samples were returned for investigation.One sample in a fully sealed, unopened pouch.One sample which does not appear to have been used.One sample which appears to have been used.The sample which appears to have been used contains hair from the patient and some small skin pieces.There are no marks on the pad or surrounding foam or wire to indicate a burn to the patient or failure with the product.The samples were review through quality with no issues found in the inspection performed.There were no visible spots, no burn marks.From a root cause analysis perspective, 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.It is important to read, understand and follow the care instructions included with the product.Care should be taken to properly prepare the patient skin prior to electrode application.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.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.Based upon the investigative details and the root cause evaluation, no corrective or preventative actions are required to be taken at this time in relation to the customer described event.We will continue to trend this defect for future occurrences as part of the complaint review process.

• 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
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12356690
• MDR Text Key: 267832828
• Report Number: 1219103-2021-00336
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2021
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 93 KG