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

Model Number	31469219
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Sparking (2595)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	01/10/2024
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 patient was shocked three times successfully and on the fourth shock, arcing and sparks came from the pad.It was noted that the pad was possibly coming off/not adhering well on that fourth shock.She did sustain a small area of redness to her skin and when checking on her at the transfer facility, it was noted to still be just red with no blistering or anything more severe.The patient had no chest hair and was not diaphoretic.There was no additional medical intervention required.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.

• 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: 18579942
• Report Number: 9681860-2024-00002
• Device Sequence Number: 7030571
• 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): 03/08/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2024
• Supplement Date Received by Manufacturer: 01/13/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female