Catalog Number 65P045 |
Device Problem
Air Leak (1008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
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Event Description
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A report was received stating that the device was observed leaking at the cuff.After 2 hours of use, there was no remaining pressure in the cuff.No incident related medical sequela was reported.
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Manufacturer Narrative
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One used sample returned for evaluation.Simulated use testing was performed by inflating the cuff with 6 cc of air and leak tested.No leaks were detected.Unable to reproduce the reported issue.No fault found.
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Search Alerts/Recalls
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