MAUDE Adverse Event Report: COVIDIEN 3202674-005 REDIPAK 1P 10B 50C; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number PM20022

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2020

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 electrodes were delaminated.

Manufacturer Narrative

The device history record was 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, for all raw materials, subassemblies and finished product, show that all acceptance criteria inspections were within acceptable limits during the production process.No adverse conditions, special circumstances or events were noted that might have contributed to gel delamination.A picture was provided for the evaluation.The photo shows the gel having a small ripple on one pad and a more pronounced ripple of the other: the aesthetic version of delamination.The gel still filly coats the electrode-no gel loss.Aesthetic delamination is described as a permanent separation of the hydrogel from the substrate, exposing the underlying carbon vinyl with little (i.E.Area less than 1/8 inch x 1/8 inch) or no hydrogel remains on the release liner.Also, no silver/silver chloride ink is exposed.Aesthetic delamination issues will not significantly affect electrode function but may displease the clinician.The pouch in the photo shows lot 715619 with a manufacture date of 6/6/17 and an expiration date of 12/6/19 based on what is written on the pouch the customer attempted to use the product on 05/12/19.Retains of the product/lot were also inspected as part of the investigation.One same showed a small ripple, without gel being pulled from the electrode.From a root cause analysis perspective, based on the type of complaint, the photo provided and the retains of the products, the most likely root cause of the issue is related to the uv curing process, this can affect the gel body as the finished product ages and the closer it gets to the expiration date.Storage conditions can also contribute to gel delamination.Storage and usage and critical to the performance of the gel.Per the packaging instructions: the electrodes should be stored in their sealed protective pouch in a cool, dry place and out of direct sunlight.Do not open package until ready for use.Do not bend, fold, or puncture the packaging.Improper storage conditions and/or handling of the product may compromise gel properties prior to the expiration.The results of the manufacturing facility investigation were able to confirm the most likely root cause is associated with the manufacture of product and would have contributed to the reported condition.The sub-assembly gel bodies are now run on a different uv system.The gel bodies have been validated on the upstairs uv fusion system (variable power) as a process improvement.The variable power output of the upstairs uv fusion system allows more flexibility to dial in the uv intensity while mitigating excess heat generation in the oven and improving gel release from liner performance throughout the life of the product and reducing the probability of gel delamination.No further actions are required at this time.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: 3202674-005 REDIPAK 1P 10B 50C
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9580828
• MDR Text Key: 174916271
• Report Number: 1219103-2020-00245
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PM20022
• Device Catalogue Number: PM20022
• Device Lot Number: 715619
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2020
• Patient Sequence Number: 1