Model Number 2010770 |
Device Problem
Deflation Problem (1149)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 10/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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No product has been returned for evaluation.At this time alleged event could not be confirmed.Labeling review: warnings, cautions and precautions: ".Over-inflation of the cuff may cause cuff failure and subsequent tracheal damage.Cuff failure may potentially cause the cuff to deflate or herniate and block the tube airway." ".Confirm the inner diameter of the tube is unblocked after test inflation." method of use: ".Determine the size of the tube for the patient prior to intubation.Test the cuff for leakage with 15cc to 20cc of air prior to intubation of the patient.Confirm the cuff is fully deflated prior to intubation of the patient.".
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Event Description
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It was reported during procedure cuff deflated causing procedure stop.Tube was re-inflated and procedure continued as planned.No patient harm reported.
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Event Description
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Supplemental report, updated data in fields.
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Manufacturer Narrative
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The product was returned to nuvasive for examination where no product malfunction could be identified.When properly handled, the tube cuff inflated without leaks and held for two hours.Testing and interviews with end user were able to identify and confirmed that the deflation cap was reattached to the valve assembly post inflation which releases the cuff pressure as designed.The nurse practitioner and neurophysiologist were given feedback on the identified root cause.No patient injury has been reported.
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Search Alerts/Recalls
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