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

Model Number PM20203

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 287921265
• Report Number: 1219103-2022-00351
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 05/07/2022
• Type of Device Usage: A
• Patient Sequence Number: 1