MAUDE Adverse Event Report: CARDINAL HEALTH 1410Z KENDALL 1PR/PK 10PR/CA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	31469219
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
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 they had a scheduled cardioversion that used a set of the 31469219 pads and when the first shock was applied, staff saw a spark come from the pads.They thought maybe the pad was coming loose at the bottom where the cords are inserted, but that wasn¿t noticed until after a second set was removed from the packaging and noted to look similar with the loose seal at the bottom.The spark did not come from the bottom of the pad just to make that clear.They shaved the patient, who wasn¿t really too hairy according to nursing staff and applied a third set of pads that did work successfully.No patient injury was reported.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Six samples were received for the investigation.Due to the samples being placed onto white paper, gel side down, the samples could not be removed for a full examination of the gel pads.Between the adhesion of the foam outer ring and the moisture from the gel pad, the paper was adhered/absorbed into the electrode foam and gel pad.As a result, the electrodes cannot be tested electronically to measure their performance.The wire crimp of each sample was visually inspected and there were no defects identified.Testing of the wire crimp was performed on the six samples and the results were within specification.A probable root cause could not be determined because of the state of the returned samples and the limited ability for the product to be appropriately tested, therefore, the complaint could not be confirmed.Since this complaint is unconfirmed, no complaint trend exists, and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 1410Z KENDALL 1PR/PK 10PR/CA
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18468552
• Report Number: 9681860-2024-00001
• Device Sequence Number: 16915988
• Product Code: MKJ
• UDI-Device Identifier: 20192253017455
• UDI-Public: 20192253017455
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: 31469219
• Device Catalogue Number: 31469219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/18/2024
• 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