NULL BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC?; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source was identified as user interface.A dhr review was unable to be performed since no lot number was provided.
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Event Description
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It was reported that while in use, the pilot balloon port pushed into the blue housing.Trach change done to resolve the issue.
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Search Alerts/Recalls
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