MAUDE Adverse Event Report: CARDINAL HEALTH 3202674-005 REDIPAK 1P 10B 50C; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	PM20022
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the electrode exhibited delamination.Per additional information received, the delamination occurred before use on the patient and there was no impact.
Additional Manufacturer Narrative
The device history record (dhr) for lot 826053 was 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 products 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.This includes testing where the liner is peeled from the gel body electrode and inspected for delamination.This product was manufactured between 2-oct-2018 and 5-oct-2018.A sample was received in the form of a photo.The photo shows an open electrode on a pouch containing the information for the reported lot.This information included the expiration date for the product of 25-mar-2021, this indicated the product has been expired for more than nine months.There were no in-house samples as the product is well past the expiration date.Gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.The difference in bond strength can cause the gel to peel from the substrate and/or tear.Delamination is categorized as follows: an aesthetic delamination defect is characterized by 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 defects will not significantly affect electrode function but may displease the clinician.Functional delamination is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.Additionally, per our procedure, there shall be no less than 55% hydrogel remaining on the adult electrode when the release liner is removed from the electrode.There shall be no less than 78% hydrogel remaining on the adult electrode, when the area of separation includes the area of underlying conductive mat.With loss of the hydrogel no more than the percentages as defined above the electrodes retain functionally essential performance; however, the reduction in the hydrogel area with the silver/silver chloride ink being exposed may cause an increase in current density across the remaining gel area.This increases the potential for skin irritation and burns.From a root cause analysis perspective, it was not possible to determine a specific root cause however the product was well past the expiration date which could have contributed to the gel delamination.As this product is well past the expiration date no further actions are required.We will continue to trend this issue for future occurrences as part of the complaint review process.
Additional Manufacturer Narrative
Updated section d2 product code from dro to mkj.

• Brand Name: 3202674-005 REDIPAK 1P 10B 50C
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183840
• MDR Report Key: 13294331
• Report Number: 1219103-2022-00344
• Device Sequence Number: 4709592
• Product Code: MKJ
• UDI-Device Identifier: 00681490580656
• UDI-Public: 00681490580656
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PM20022
• Device Catalogue Number: PM20022
• Device Lot Number: 826053
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022; 01/04/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/16/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown