MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ECG NEONATALII,3 WIRE,TP,ADGEL; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 1741-003

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 1741-003, ecg neonatalii,3 wire,tp,adgel was being used on (b)(6) 2023 and ¿we noticed a wound in a very large premature baby (24 weeks 1/7).The injury was described as a blackened wound at the electrode site on the left.¿.Further assessment has been sent; however, to date no information has been obtained.This report is being raised due to the reported injury of blackened wound at the electrode site.

Event Description

Update: per further assessment received on (b)(6) 2024 clarification regarding (24 weeks 1/7) was "the baby was 24 weeks + 1 day".It was also found that "the nurse documented a black sore at the electrode site.In the notes, it is documented that this newborn had several bruises in other areas of his body." it was not specified in the file, "but it is standard procedure to dry the skin before installing the electrodes." it was not in the file if the electrode was difficult to remove.It is unknown if medical surgical/intervention was needed as "the patient was transferred to another center (not related to the electrode injury).So we don't have much information about the newborn." there was an extended stay at the hospital for the patient; however, "not related to electrode wound".The electrode worked well during the procedure.The sales representative reported on behalf of the customer that the 1741-003, ecg neonatalii,3 wire,tp,adgel was being used on (b)(6) 2023 and ¿we noticed a wound in a very large premature baby (24 weeks 1/7).The injury was described as a blackened wound at the electrode site on the left.¿.Further assessment has been sent; however, to date no information has been obtained.This report is being raised due to the reported injury of blackened wound at the electrode site.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review shows a total of two (2) devices for this lot number and failure mode.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised the following: during surgical procedures place ecg electrodes and leads as far as possible from the electrosurgical site to minimize rf current flow through the ecg electrodes.Placement is important in reducing the potential for patient harm in the event of a defect in the dispersive electrode.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ECG NEONATALII,3 WIRE,TP,ADGEL
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 18391750
• MDR Text Key: 331292219
• Report Number: 3007305485-2023-00259
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 30653405004336
• UDI-Public: (01)30653405004336(17)250330(10)202303315
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K901555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1741-003
• Device Lot Number: 202303315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Ethnicity: Non Hispanic