MAUDE Adverse Event Report: CARDINAL HEALTH 3010188-020 QC RTS 1/P 10/B 50; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number PM20003

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer of stryker (b)(6) complained of delamination of the electrode.

Manufacturer Narrative

A review of the device history record showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations or non conformances initiated with this lot code.A sample was not received with this complaint therefore, it is not possible to confirm the reported condition.From a root cause analysis perspective, gel delamination could occur if the silver printed carbon substrate does not bond with the gel, or liner.The results of the manufacturing facility investigation were unable to confirm an exact root cause associated with the manufacture of product the root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 3010188-020 QC RTS 1/P 10/B 50
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• 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 ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12392778
• MDR Text Key: 270525300
• Report Number: 1219103-2021-00337
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 00721902195037
• UDI-Public: 00721902195037
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PM20003
• Device Catalogue Number: PM20003
• Device Lot Number: 007721
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1