MAUDE Adverse Event Report: CARDINAL HEALTH 3010188-023 QC RTS 1/P 10/B 50/CS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	PM20203
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 received product where the package was empty and did not contain the defib electrode.This was noticed on incoming inspection.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.A sample was received in the form of a photo of an unopened flat pouch.The photo clearly shows a flat pouch indicating there is no product inside.From a root cause analysis perspective, this is manufacturing related.Based on the process, someone sealed an empty pouch and applied a barcode label to the pouch.The barcode label is applied during the packing process as the pouch is being inspected for seal and pouch defects.It is possible the pouch was supposed to be a sample for someone and was mistakenly packed or the pouch was setup to be used for an inspection test and was accidentally packed.A review of the case report will be conducted with each employee listed on the production report based on the label number provided in the photos.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: 3010188-023 QC RTS 1/P 10/B 50/CS
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• 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: 13869210
• Report Number: 1219103-2022-00351
• Device Sequence Number: 5296178
• Product Code: MKJ
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• 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): 05/06/2022

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: PM20203
• Device Catalogue Number: PM20203
• Device Lot Number: 103642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/07/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown