Catalog Number K09-04816J |
Device Problem
Air Leak (1008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that during a coronary angiography procedure, air was noticed leaking into the manifold from rotator connection.The air was successfully managed by the clinician throughout the procedure.No patient injury to report.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the complaint database was performed and no similar complaints were found for this lot number.A review of the device history record was performed and no exception documents were found.
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Search Alerts/Recalls
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