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

Model Number 22660R-

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that after testing the defib pads they noticed discoloration on the apex side.Upon review of the photo that was provided by the customer, one pad had an area of gel delamination.

Manufacturer Narrative

The device history records (dhr) were reviewed for both the finished good and the sub-assemblies manufactured at the plant, 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.Physical samples were not returned however a write up containing photos indicating the complaint and product was provided.The photos specific to these complaints show two sets of electrode pads.The set designated as lot 930516x (pad set # 1) indicates the product was tested from 20 joules through 200 joules with not issues and passing tests.The samples were then put through another series of tests where at 100 joules the samples started to react and at 200 joules the ¿reading output failed¿.When the electrodes were visually inspected after the test the apex side showed a brown discoloration.The discoloration was in the shape of the metal plate used for the testing.The photos of the sternum side have gel delamination in the center of the pad.From a root cause analysis perspective, the possible causes that would result in the discoloration and delamination as seen in the photos is a possible chemical reaction based on the type of test performed.The test performed uses a metal plate sandwiched between the electrodes, the metal reaction with the samples could discolor the product as seen.The discoloration is only found where the shape of the metal plate was which would suggest this is part of the issue.It is also possible the repeated shocks can result in the discoloration of the silver as it reacts to the electricity.As the process used was not disclosed and the samples were not returned it is not possible to determine the impact.For delamination the gel could have a reaction to the metal plate in that the gel sticks to surface of the plate more than to the substrate.Testing performed in the manufacturing plant is to test the gel release from the liner.Possible manufacturing causes for delamination are related to the uv curing process, which can affect the electrode gel body particularly as the finished electrodes ages.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: CADENCE HEARTSTREAM ADULT RTS
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11343128
• MDR Text Key: 232367399
• Report Number: 1219103-2021-00315
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022349
• UDI-Public: 20884527022349
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2021
• Device Model Number: 22660R-
• Device Catalogue Number: 22660R-
• Device Lot Number: 930516X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Patient Sequence Number: 1