Catalog Number 955610 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Shock (2072); Loss of consciousness (2418)
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Event Date 02/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a patient experienced a drop in blood pressure, respiratory discomfort, shock and obnubilation shortly after starting treatment and the patient became unconscious.The patient was administered oxygen and urgent fluid replacement.The patient recovered from the event.No additional information is available.
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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