MAUDE Adverse Event Report: COVIDIEN ELECTRODE ADULT 4.5X6.25 DEFIBRILATION; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22550A

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported the defib electrodes was sparking during treatment of a 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 by the customer.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.There were no samples received with this complaint therefore an examination of the device was not possible.There were photographs provided for analysis; the photos showed the pouch and the label.The photos did not show the product.From a root cause analysis perspective, the customer stated they did an internal investigation into the issue and concluded the issue was not caused by the pads but due to other factors with the patient.The patient was a very hairy individual who had copious amounts of secretion at the time.They do not feel the pads were the issue because during the code the pads were changed and there were no issues with the new set.The results of the manufacturing facility investigation were 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 are necessary.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: ELECTRODE ADULT 4.5X6.25 DEFIBRILATION
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11931395
• MDR Text Key: 254059440
• Report Number: 1219103-2021-00324
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022301
• UDI-Public: 20884527022301
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/29/2023
• Device Model Number: 22550A
• Device Catalogue Number: 22550A
• Device Lot Number: 112095X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Patient Sequence Number: 1