Model Number 8DIC |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the unit's inner cannula was blocked and did not allow air to pass.The customer reported that there was no confirmation for the patient outcome.
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Manufacturer Narrative
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Additional: (udi #).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Evaluation summary: one sample was received for evaluation and the reported event was confirmed.A visual inspection was performed, and it was observed the inner diameter of the cannula is occluded with a piece of plastic.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, when the nurse was performing trach care, upon changing the inner cannula, the vent immediately started alarming and the patient displayed signs of respiratory distress.It was stated that the nurse attempted to suction the patient and could not advance the tubing due to meeting resistance.She got another cannula and swapped it.Once she removed the inner cannula, she inspected it and learned that it was blocked with a piece of plastic.Other than the initial short term respiratory distress, there was no other harm caused to the patient.
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Manufacturer Narrative
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Correction: (udi #).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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