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

Model Number	22550A
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the defib electrodes was sparking during treatment of a patient.
Additional 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
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11931395
• Report Number: 1219103-2021-00324
• Device Sequence Number: 4395424
• Product Code: DRO
• UDI-Device Identifier: 20884527022301
• UDI-Public: 20884527022301
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1