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 05/12/2021

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 with the defibrillation electrodes.There were no burns to the patient's skin and the patient seemed to be unharmed.

Manufacturer Narrative

H3: evaluation summary: 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 review shows that all acceptance criteria inspections were within acceptable limits during the production process.One set of used and 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.Further inspection was not possible as the samples were stuck to the pouch and the print from the pouch transferred to the electrode.It is difficult to determine what is print and what could be another issue.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.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 problems 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 of the skin could result in a spark.The product being used in an oxygen rich environment could also produce a spark during testing.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of 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: 11901191
• MDR Text Key: 253171367
• Report Number: 1219103-2021-00322
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• 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: 106361X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2021
• Patient Sequence Number: 1