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

Catalog Number 1741-003

Device Problem Temperature Problem (3022)

Patient Problem Blister (4537)

Event Date 01/13/2021

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 1741-003, was being used for monitoring on (b)(6) 2021 when it was reported "small blister noted to patient's right upper chest under cardiac monitor lead." further assessment questions were sent to the reporter; however, to date no further assessment information has been received.This report is being raised on the basis of injury due to reported patient blistering (burn).

Manufacturer Narrative

The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The manufacturing documents from the device history record have not been reviewed because the lot number is not available.A two-year lot history review could not be performed since a lot number was not provided.(b)(4).Per the instructions for use, the user is advised that 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.This issue will continue to be monitored 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; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 11300635
• MDR Text Key: 231010220
• Report Number: 3007305485-2021-00064
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K901555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other