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Catalog Number 99576-000044 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Liver Laceration(s) (1955)
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Event Date 03/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device was not returned to physio-control for evaluation.The customer confirmed the stabilization strap were not used, the gel from the patient¿s chest was not removed, and the healthcare providers made an active decision to let compressions continue though there were concerns regarding proper device placement.The instructions for use were not followed that include warnings and cautions for incorrect positioning of the device and inadequate gel removal before usage.Based on the information provided, there was no indication of a device malfunction.Device not evaluated by manufacturer.
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Event Description
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The customer contacted physio-control to report that their device had potentially caused a liver bleed during a resuscitation.An echo had been performed during the event, for which gel had been applied to the patient's chest.The gel had been left on the patient's chest when the device was applied.No stabilization straps could be deployed, because of other activities.During the use it was observed that the device had to be moved further up the chest to a more superior position on the sternum.Subsequently, the healthcare provider still felt the position wasn't high enough.A decision was then made that it would be detrimental to stop compression.The liver bleed was discovered after the resuscitation and the patient was provided with further treatment.The patient survived the reported event.
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Search Alerts/Recalls
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