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

Model Number 22550R-

Device Problem Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

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 that the staff was performing a cardioversion when the team smelled something burning.The team was able to determine that the burning smell was coming from the patch that was on the patient.There was no injury to the patient.

Manufacturer Narrative

The device history records (dhrs) were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr reviews show that all acceptance criteria inspections were within acceptable limits during the production process, this testing includes peel testing to inspect for delamination.One sample was received at the manufacturing site for the investigation.The sample arrived with an ¿x¿ on one of the electrodes and was adhered to a plastic bag.Visual inspection showed that the product had no signs of burn marks.No visual issues of any kind were found.Electrical testing was performed on the sample and no burning smell was present during the testing.Test results showed elevated impedance testing which is expected since the product was used and was exposed to air and had started to dry out.The wires and plugs were inspected, and no issues were found with either.The reported issue could not be confirmed.From a root cause perspective, as the manufacturing site was unable to recreate the defect it is not possible to determine a cause of the burning smell.It is important to note that these electrodes provide a reduced skin irritation, but do not eliminate skin irritation.Erythema¿s, 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¿s 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 the 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.The complete reports are available upon request.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 investigation were unable to confirm any potential root causes associated with the manufacturing of this product which would have contributed to the reported condition.No corrective or preventative actions are necessary at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to trend this issue for future occurrences as part of the complaint review process.This complaint will be used for 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: 9977919
• MDR Text Key: 190319494
• Report Number: 1219103-2020-00282
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• 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: 935035X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2020
• Patient Sequence Number: 1