MAUDE Adverse Event Report: CARDINAL HEALTH 3201616-011 KIT LIFEPAK CR-PLUS 1EA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	CHP31021
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported their customer reported that they received a chargepack kit which was missing the electrodes - only the battery was in the box.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review showed all acceptance criteria inspections were within acceptable limits during the production process.No samples were received for this case, but based on the type of issue reported, no sample is needed.An exact root cause could not be determined with the information available.Awareness training through a quality alert was issued.The need for further scale verification, process improvements and/or product inspection was reviewed.No further corrective or preventative actions are necessary.This complaint will be used for tracking and trending purposes.

• Brand Name: 3201616-011 KIT LIFEPAK CR-PLUS 1EA
• 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: 19309750
• Report Number: 1219103-2024-00002
• Device Sequence Number: 20560759
• Product Code: MKJ
• UDI-Device Identifier: 00883873824597
• UDI-Public: 00883873824597
• 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
• Report Date (Section B): 06/14/2024

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: CHP31021
• Device Catalogue Number: CHP31021
• Device Lot Number: 233322
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/14/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown