DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON(IAB); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/06/2023 |
Event Type
Injury
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) unit froze up.The system was rebooted and therapy was resumed, however, the patient had a drop in hemodynamics during and after the event.It was advised by the getinge representative to change to an alternate cardiosave iabp if available.The team was guided on how to transfer therapy to a different cardiosave with minimal downtime.Rn stated the patient had a drop in hemodynamics during and after the event.However, the patient is currently stable and hemodynamics have improved back to pre-event conditions.This report is for the iab.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-01527.
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Manufacturer Narrative
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Additional contact person information - valerie nolan rn charge/ rose, rn.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint#: (b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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