CONSOLIDATED MEDICAL EQUIPMENT ECG NEONATALII,3 WIRE,TP,ADGEL; ELECTRODE, ELECTROCARDIOGRAPH
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Catalog Number 1741-003 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Blister (4537)
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Event Date 01/13/2021 |
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.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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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).
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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