MAUDE Adverse Event Report: CARDINAL HEALTH MEDITRACE RTS FOR MEDTRONIC; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 20550-

Device Problem Peeled/Delaminated (1454)

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

Customer reports: the adhesive is coming off the defib pad.

Manufacturer Narrative

The device history records (dhrs) were reviewed for any problems and disparities.All process parameters, product, raw materials, and sub-assembly components met the required acceptance criteria to completely satisfy the manufacturing requirements per the product specification.No adverse conditions, special circumstances, or events were documented that may have led to the gel delamination.Physical samples were not returned however photographs were provided.The photo appears to show gel missing from one half of the gel body.The gel appears yellow in color.There is no photo of the liner and no information regarding where the remaining gel is or how this occurred.Based on the complaint description, the photos, and the investigation, as described by the customer gel delamination is confirmed.It is not possible based solely on photos to determine what might have caused the issue.Additionally, gel delamination is possible if the defib electrodes are not properly stored.As indicated on the product packaging proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed protective pouch in a cool, dry place and out of direct sunlight.Improper storage conditions and/or handling of the product may compromise gel properties prior to the expiration.It was not possible to verify a cause related to a manufacturing process, therefore no preventive or corrective actions are being taken at this time.The complaint details were communicated to the manufacturing group to heighten awareness.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: MEDITRACE RTS FOR MEDTRONIC
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 16632054
• MDR Text Key: 312298215
• Report Number: 1219103-2023-00369
• Device Sequence Number: 1
• Product Code: DRO
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 20550-
• Device Catalogue Number: 20550-
• Device Lot Number: 206335X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1