CONSOLIDATED MEDICAL EQUIPMENT COMPANY ECG NEONATALII,3 WIRE,TP,ADGEL; ELECTRODE, ELECTROCARDIOGRAPH
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Catalog Number 1741-003 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 10/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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