Model Number 8LPC |
Device Problem
Air Leak (1008)
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Patient Problem
Extubate (2402)
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Event Type
Injury
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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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Event Description
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Medtronic received a report that the tracheostomy cuff would not hold air.Re-incubation of a replacement tube was required.
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Manufacturer Narrative
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One sample was received for analysis and the reported issue was confirmed.A inflation/deflation test was performed and it was observed the cuff deflated immediately.A visual inspection was performed and it was observed that the cuff was cut.Manufacturing controls are in place to detect cuffs with damage and to reduce the potential for occurrence during the manufacturing process.Information has been added to the database and trends will continue to be monitored.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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