MAUDE Adverse Event Report: COVIDIEN MEDITRACE RTS FOR ZOLL; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 20770

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

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

The customer reported when they remove the defib pads, the adhesive stayed behind on the patient's chest and the connection cables seem shorter than before.There was no harm to the patient.

Manufacturer Narrative

The device history records (dhrs) were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Samples were not received for the investigation.Because a sample was not returned, the investigation was performed using retains from the production lot.A visual inspection was completed and found that there was no delamination of the gel observed when the liners were peeled from the gel.Electrical testing was also performed and there were no issues found.Measurements of the wires were then performed.Per the raw material specification, the wires should measure 47.0 inches to 48.0 inches.The wires measured 45.5 inches from the end of the plug to the end of the wire.This has been identified as a raw material supplier issue.A quality alert will be issued to the supplier.This action is designed to prevent the recurrence of this issue.From a root cause analysis perspective, it should be noted that there are several important factors that can impact the adhesion of the product.The use of this product requires an adherence to proper skin preparation protocols as documented on the product packaging.Improper application of the electrode or applications without proper skin preparation can cause adhesion issues.Proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed, foil lined pouches away from extreme heat and humidity.The electrodes are single use and should not be used more than once.Failure to do so could result in adhesion issues where the electrode is not adequately adhered to the patient due to skin preparation.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product at cardinal health which would have contributed to the reported condition.No further corrective actions are necessary at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to trend this issue for future occurrences as part of our complaint review process.This complaint will be used for tracking and trending purposes.

• Brand Name: MEDITRACE RTS FOR ZOLL
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 10612492
• MDR Text Key: 209348279
• Report Number: 1219103-2020-00304
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527015617
• UDI-Public: 20884527015617
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20770
• Device Catalogue Number: 20770
• Device Lot Number: 930503X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2020
• Patient Sequence Number: 1