Catalog Number 0684-00-0575 |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon therapy, the intra-aortic balloon failed to deliver arterial pressure signal to the console and the console alarmed "sensor failure." the indication for therapy was stemi=st elevation myocardial infarction.There was no reported injury to the patient.
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Manufacturer Narrative
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Complaint # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon therapy, the intra-aortic balloon failed to deliver arterial pressure signal to the console and the console alarmed "sensor failure." the indication for therapy was stemi=st elevation myocardial infarction.There was no reported injury to the patient.
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Search Alerts/Recalls
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