CONSOLIDATED MEDICAL EQUIPMENT COMPANY ECG NEONATALII,3 WIRE,TP,ADGEL; ELECTRODE, ELECTROCARDIOGRAPH
|
Back to Search Results |
|
Catalog Number 1741-003 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Burn(s) (1757)
|
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 and ¿(b)(6)2023: an injury was caused by the removal of the electrode during the newborn's bath, described visually as a burn.Exact date is unknown.¿.Further assessment has been sent; however, to date no information has been obtained.This report is being raised due to the reported injury of unknown degree of burn.
|
|
Event Description
|
The sales representative reported on behalf of the customer that the 1741-003, ecg neonatal ii,3 wire,tp,adgel was being used and ¿(b)(6) 2023: an injury was caused by the removal of the electrode during the newborn's bath, described visually as a burn.Exat date is unknown.¿.Further assessment has been sent; however, to date no information has been obtained.This report is being raised due to the reported injury of unknown degree of burn.
|
|
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.A two-year review of complaint history revealed there has been a total of 8 reports, regarding 14 devices, for this device family and failure mode.(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.
|
|
Search Alerts/Recalls
|
|
|