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

Model Number	PM20003
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported they were contacted about an end user that found the gel is tearing away from the electrode.There was no patient harm.
Additional Manufacturer Narrative
H6 investigation findings - 4247: undetermined.The device history records (dhrs) of various subassemblies and the finished good were reviewed.The dhr reviews showed that no abnormal process conditions were present during the manufacturing of the product that would have led to the reported condition.The dhr reviews also were performed for the gel body lots as well as all the subassembly gel mixes.The dhr reviews show that all acceptance criteria were met ¿ including all tests, inspections, and process conditions.Samples were received in the form of 4 unopened/sealed pouches.Visual inspection of the pouches did not show any damage to the pouch or the seal.Visual inspection of the product prior to testing did not show any signs of damage or anything that may have indicated an issue with the product.Physical testing was performed on the samples using the single direction peel test.This is a test that uses an instron to peel the gel body from the liner and to inspect for gel delamination.This test resulted in delamination on the samples returned, with over 50 percent of the gel delaminating from the silver portion of the gel body.The test results from the returned samples showed delamination where the gel had a tighter bond to the liner than the silver and carbon vinyl that it is designed to be tightly bonded to.Retain samples of the finished product lot were procured and peeled in a similar way of a clinical event.For the retain pm20003 electrodes, the electrodes removed from the liner without any evidence of gel delamination.Five additional retained samples underwent single direction peel testing, with the testing showing no evidence of gel delamination.The results of the manufacturing facility investigation was unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.No corrective or preventative actions will be taken at this time.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: 3010188-020 QC RTS 1/P 10/B 50
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12025014
• Report Number: 1219103-2021-00329
• Device Sequence Number: 3388615
• Product Code: DRO
• UDI-Device Identifier: 00721902195037
• UDI-Public: 00721902195037
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: PM20003
• Device Catalogue Number: PM20003
• Device Lot Number: 004827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown