MAUDE Adverse Event Report: CARDINAL HEALTH 3010107-007 QC RTS PD 1/P 25/CS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	PM20212
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
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 they opened a set of rts defib electrodes and the gel was peeling off.Pharmaco warehouse checked 4 additional units in the warehouse and 2 have the same issue.
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.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.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Sections h3 and h6 evaluation codes were updated.Updated investigation summary: the device history record was reviewed and indicated the product was released accomplishing all quality standards.A photo was provided and visually inspected; the reported issue was observed.A retained device was tested and did not show signs of delamination.No abnormal conditions were found in our process that could trigger this issue.All information received will be used for tracking and trending purposes and we will continue to monitor.H6 evaluation code "type of investigation", investigation findings" and "investigation conclusions" were updated.

• Brand Name: 3010107-007 QC RTS PD 1/P 25/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: 20461764
• Report Number: 1423537-2024-00241
• Device Sequence Number: 18318265
• Product Code: MKJ
• UDI-Device Identifier: 00883873784952
• UDI-Public: (01)00883873784952(11)230428(17)241028(10)313212
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K980857
• 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,Followup
• Report Date (Section B): 11/04/2024

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 Expiration Date: 10/28/2024
• Device Model Number: PM20212
• Device Catalogue Number: PM20212
• Device Lot Number: 313212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/04/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown