MAUDE Adverse Event Report: CARDINAL HEALTH 3202674-006 REDIPAK 1/P 10/B 50/CS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	PM20222
Medical Device Problem Code	Component Missing (2306)
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 that they found a pack of pm20222, lot 331026 to contain one pad instead of two.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: 3202674-006 REDIPAK 1/P 10/B 50/CS
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21264316
• Report Number: 1423537-2025-00055
• Device Sequence Number: 9475573
• Product Code: MKJ
• UDI-Device Identifier: 50883873784964
• UDI-Public: (01)50883873784964(11)231127(17)260527(10)331026
• 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): 01/30/2025

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: 05/27/2026
• Device Model Number: PM20222
• Device Catalogue Number: PM20222
• Device Lot Number: 331026
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown