Lot Number UNKNOWN |
Device Problems
Device Alarm System (1012); Loss of Power (1475)
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Patient Problem
Chest Pain (1776)
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Event Date 12/02/2018 |
Event Type
Injury
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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.If provided we will send a supplemental report with our additional findings.(b)(4).
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Event Description
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It was reported that during use on a patient the intra-aortic balloon pump (iabp) suddenly alarmed "internal communication failure" and powered off by itself.The nurse restarted the iabp unit and continued therapy without incident.It was suggested to the customer to switch out the iabp unit when and if cleared with the doctor and to have the initial iabp serviced.During the event the patient experienced severe chest pain.There was no reported malfunction of the intra-aortic balloon (iab).
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Manufacturer Narrative
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Complaint # (b)(4); record id 192914.
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Event Description
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It was reported that during use on a patient the intra-aortic balloon pump (iabp) suddenly alarmed "internal communication failure" and powered off by itself.The nurse restarted the iabp unit and continued therapy without incident.It was suggested to the customer to switch out the iabp unit when and if cleared with the doctor and to have the initial iabp serviced.During the event the patient experienced severe chest pain.There was no reported malfunction of the intra-aortic balloon (iab).
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Search Alerts/Recalls
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