MAUDE Adverse Event Report: CARDINAL HEALTH 3010188-024 QC STD 1/P 10/B 50/CS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	PM20205
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 an electrode with delamination.
Additional Manufacturer Narrative
H6 investigation findings - 4247: undetermined.The device history records (dhrs) were reviewed for any problems and disparities.A dhr review provides information that could reveal any unusual circumstances that may have led to the issues at hand.All process parameters, product, raw materials, and sub-assembly components met the required acceptance criteria to completely satisfy the manufacturing requirements per the product specification.No adverse conditions, special circumstances, or events were documented that may have led to the gel delamination.In addition, the dhr was reviewed for the hydrogel body subassembly lot that was used.The dhrs for the hydrogel body sub-assemblies met all acceptance criteria.The hydrogel body sub-assembly lot number was manufactured in april 2021.Raw material records were reviewed as well, and all acceptance criteria was met.The uv dosage outputs for curing the hydrogel bodies were within the proper range.The conductive silver/silver chloride ink and gel batch mix sheets were also reviewed.All components and mix time were within tolerance.During the production of hydrogel bodies, single direction peel testing is performed to simulate the removal of the electrode release liner by a clinician prior to delivering therapy (product is lifted from the liner to evaluate for release of gel from the substrate).The product met the testing requirements.The product was released in april 2021 with a product use by date of 17oct2023.There were photos of the product provided as part of the complaint report.One of the photos is of the pouch, verifying the product/lot information.One photo appears to be of the product prior to peeling the liner from it.Two other photos show the product with stretched gel and ripples through it.Based on the complaint description and the photos provided, the allegation of gel delamination is confirmed.However it was not possible from the photos to determine what might have caused the issue.A corrective and preventive action (capa) has been opened to investigate gel delamination on defibrillation electrodes.Additionally, gel delamination is possible if the defib electrodes are not properly stored.As indicated on the product packaging proper storage and usage of the electrodes is critical to the performance of the gel.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.Since a capa has been opened to investigate this issue, no further actions are needed at this time.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: 3010188-024 QC STD 1/P 10/B 50/CS
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15124625
• Report Number: 1219103-2022-00359
• Device Sequence Number: 7323387
• Product Code: MKJ
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/23/2023
• Device Model Number: PM20205
• Device Catalogue Number: PM20205
• Device Lot Number: 111899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 08/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown