Catalog Number 0684-00-0575 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/11/2019 |
Event Type
malfunction
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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.Complaint record id # (b)(4).
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Event Description
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It was reported during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.Central lumen being used as arterial pressure source.There was no reported injury to the patient.
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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.Complaint record #(b)(4).
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Event Description
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It was reported during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.Central lumen being used as arterial pressure source.There was no reported injury to the patient.
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Search Alerts/Recalls
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