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 05/28/2021

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 they had a set of pads that arched and smoked a little when the patient was cardioverted.There was no harm to the patient.Additional information received: the arching/smoke was seen at the distal end of the pads where the wires enter the pad.The cardioversion was successful in delivering 200 joule shocks to the patient.

Manufacturer Narrative

Additional information added: h6 evaluation code: type of investigation; investigation findings; investigation conclusions.Investigation 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 as described by the customer.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.One set of used, unsealed samples were returned along with photos for analysis.A visual inspection was performed.The visual inspection was made more difficult by the product being stuck to the pouch.It was not possible to see any marks or patterns because the print from the pouch transferred to the electrodes.A finished goods wire testing was performed on the returned sample.The test runs electrical current through the wires to ensure no breaks or disruptions.No issues were found.It was not possible to perform further electrical testing due to the product having been stuck to the pouch and residue from the pouch being transferred to the electrode.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 defects 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.We 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: 11979331
• MDR Text Key: 255716829
• Report Number: 1219103-2021-00326
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: 05/28/2021
• Patient Sequence Number: 1