MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY NEOTRODE; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number	1741-003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Event or Problem 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.
Additional Manufacturer Narrative
Correction: d1 brand name was corrected to neotrode 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 (b)(4) 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.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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).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: NEOTRODE
• Common Device Name: 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
• Report Number: 3007305485-2023-00259
• Device Sequence Number: 18334672
• Product Code: DRX
• UDI-Device Identifier: 30653405004336
• UDI-Public: (01)30653405004336(17)250330(10)202303315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K901555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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: Health Professional
• Device Expiration Date: 03/30/2025
• Device Catalogue Number: 1741-003
• Device Lot Number: 202303315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 01/16/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/19/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic