MAUDE Adverse Event Report: CARDINAL HEALTH 3010188-021 QC STD 1/P 10/B 50; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	PM20005
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.Per customer, gel came off the pad and onto the patient skin.The customer further stated that the patient was successfully cardioverted.There was no harm reported.
Additional Manufacturer Narrative
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¿s were reviewed for hydrogel body subassembly that were used.The dhr¿s for the hydrogel body sub-assemblies met all acceptance criteria.The hydrogel body sub-assembly lot numbers were manufactured in may 2019.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 june/july 2019 with a product use by date of 24dec2021.Based on this information it was noted that the product has been expired for more than 6 months.There were no samples received with this complaint therefore an examination of the reported issue could not be made.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.It is not possible to determine if this is manufacturing related or related to the product expiration.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.Section d1 (brand name): originally reported as 3010188-024 qc std 1/p 10/b 50/cs and should be 3010188-021 qc std 1/p 10/b 50.Section d4 (model number and catalog number): originally reported as pm20205 and should be pm20005; unique identifier (udi) #: originally reported as (b)(4) and should be (b)(4); lot number: originally reported as 914757 and should be 914747.

• Brand Name: 3010188-021 QC STD 1/P 10/B 50
• 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: 15133429
• Report Number: 1219103-2022-00362
• Device Sequence Number: 6482302
• Product Code: MKJ
• UDI-Device Identifier: 40721902195073
• UDI-Public: 40721902195073
• 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): 09/06/2022

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 Model Number: PM20005
• Device Catalogue Number: PM20005
• Device Lot Number: 914747
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown