TELEFLEX MEDICAL LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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Catalog Number 1D2040 |
Device Problems
Shelf Life Exceeded (1567); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The investigation into this complaint is still in progress at the time of this report.
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Event Description
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Customer complaint alleges"the cuff pilot valve was not working properly.When attempting to deflate or inflate the cuff, the valve seemed stuck." alleged defect reported as detected during pre-testing, prior to patient use.There was no report of patient harm or delay in treatment.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Customer complaint alleges"the cuff pilot valve was not working properly.When attempting to deflate or inflate the cuff, the valve seemed stuck." alleged defect reported as detected during pre-testing, prior to patient use.There was no report of patient harm or delay in treatment.
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Search Alerts/Recalls
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