Model Number 6DIC |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Irritation (1941)
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Event Date 01/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
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Event Description
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Customer reported that during a routine trach replacement the patient felt very uncomfortable.It was reported that during visual examination upon removal of the tube the inner cannula appeared to exceed the length of the outer cannula.Follow up efforts were performed to obtain additional information related to this report and new information provided on (b)(6) 2017 revealed that the patient is being treated with antibiotics for possible pneumonia due to poor secretion and irritation to the tracheal wall.The customer reported that the exceeded length of the inner cannula resulted in irritation to the tracheal wall however; the replacement of the tube was routine replacement and not a result of the reported inner cannula issue.The new information provided also revealed that the patient is currently stable.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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