Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Shock (2072)
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Event Date 11/23/2018 |
Event Type
malfunction
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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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Event Description
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It was reported that a patient went into shock and experienced a drop in blood pressure approximately 1.5 hours into treatment with a prismaflex machine.The treatment was immediately terminated.No further medical intervention was reported.The patient outcome was not reported.No additional information available.
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Manufacturer Narrative
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The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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