MAUDE Adverse Event Report: COVIDIEN MEDI-TRACE# CADENCE ADULT RTS ZOLL; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22770R

Device Problem Device Emits Odor (1425)

Patient Problem Burn(s) (1757)

Event Date 02/13/2020

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 defibrillation patches were applied anterior/posterior to chest and back and connected to a defibrillator, after the initial shock of 150 joules and unsuccessful cardioversion the staff noticed a faint burning smell and heard a pop.The pad placement and adherence were checked and agree to be correctly placed and adhered.The second shock was delivered at 200 joules, cardioversion was successful with similar result of burning smell.After the pads were removed the patient was found to have small burn marks on mid-chest but none on the back.The prominent burn mark was approximately 4 cm long with several smaller marks scattered where the edge of the pad had been.Silvadine was applied to the area per physician's order.

Manufacturer Narrative

H 3 evaluation summary the device history record (dhr) was reviewed for the reported lot and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Samples were received from the customer in the form of one set of electrodes with the foil pouch.The sample was received open and used.Visual inspection of the sample showed no noticeable defects in the product.The wire is correctly fanned, and the gel is intact.Electrical testing was performed and while the values are higher than usual, this can be attributed to the fact that the product is used and was left exposed during shipping.The electrical results while higher are still within the acceptable tolerance for the product.From a root cause analysis perspective, it is important to note these electrodes provide a reduced skin irritation, but do not eliminate it.Erythema, burns, and even blisters, while not desirable, are not uncommon consequences of defibrillation or cardioversion.To help the electrode make good skin contact and to help reduce contact impedance, the product labeling instructions and warnings should be followed.These instructions will ensure optimal adhesion and minimize potential patient skin burns.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of the product which would have contributed to the reported condition.No corrective or preventative actions are necessary.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: MEDI-TRACE# CADENCE ADULT RTS ZOLL
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9891812
• MDR Text Key: 187558462
• Report Number: 1219103-2020-00278
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022400
• UDI-Public: 20884527022400
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22770R
• Device Catalogue Number: 22770R
• Device Lot Number: 934328X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/09/2020
• Patient Sequence Number: 1