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

Model Number 22770R

Device Problem Arcing (2583)

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

Event Date 05/26/2021

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.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 arcing occurred, black residue around rim was observed.The black residue was left on patient which was able to be wiped off.There was smoke coming from the product.There was no patient harm reported.

Manufacturer Narrative

H3 evaluation summary: 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.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.One set of used open, unsealed samples were returned along with photos for evaluation.A visual inspection was performed.There was some hair noted on the electrodes.There did not appear to be any burn areas on the electrodes.There were no burn marks or areas on the wires.There are no breaks in the wires.Finished good wire testing was performed on the sample with a passing test.This indicates electricity is flowing through the wire set with no issues.There was a substance on the wire a few inches from the plug.We were unable to determine what the substance was.An inspection of the manufacturing line did not show any such substance.Retain samples were also tested and no issues or anomalies were found.From a root cause analysis perspective, the investigation was unable to determine any possible manufacturing causes for the arcing.The sample returned shows no burn marks or issues that would relate to manufacturing.The investigation determined there are a couple of causes which could be related to set up or usage.It is important to follow proper skin preparation prior to use.Fabric fibers or chemical residue left on the skin could result in a spark.The product being used in an oxygen rich environment could also produce a spark during testing.No corrective and preventative actions (capa) are necessary.The manufacturing site 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: 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: 12018427
• MDR Text Key: 256778302
• Report Number: 1219103-2021-00328
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 106360X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2021
• Patient Sequence Number: 1