MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ECG PEDIATRIC; 2331C-003; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	2331C-003
Medical Device Problem Codes	Human-Device Interface Problem (2949); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of the customer's reported event that ¿patient swallowed electrode after breaking it apart¿ finds it to be unconfirmed.The device in question is not available for evaluation by conmed.Photographic evidence has been provided however it does not exhibit any evidence of the reported event.Therefore, the reported failure cannot be verified, and the complaint is unconfirmed.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 13,448,400 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also per the ifu the user is advised that no modification of electrodes is allowed.Modification may result in patient or operator harm.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of the customer, the conmed representative reported issues with the ecg pediatric electrode (softrace medium rtl) item # 2331c-003, lot 202106105, that was experienced on (b)(6) 2021.Information received indicates only that the patient swallowed electrode after breaking it apart¿ it is noted a surgical procedure was need to retrieve electrode from patient.The patient status is listed to be ¿stable¿.Additional information provided indicates the patient involved was under 1 year of age.The issue occurred while patient was in the nicu and the device was being used for general monitoring.It is unknown where on the patients body the device was located or how long the device had been in place when the issue occurred.It is unknown where the pieces of the device were found in the patient during the surgery, only that all pieces were removed.No other clarification was provided.This report is being raised on the basis of injury as a surgical procedure was needed to remove the pieces after ingestion.

• Brand Name: ECG PEDIATRIC; 2331C-003
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12372102
• Report Number: 3007305485-2021-00354
• Device Sequence Number: 4334019
• Product Code: DRX
• UDI-Device Identifier: 30653405064132
• UDI-Public: (01)30653405064132(17)230610(10)202106105
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K901555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 06/10/2023
• Device Model Number: 2331C-003
• Device Catalogue Number: 2331C-003
• Device Lot Number: 202106105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention