TELEFLEX MEDICAL LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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Catalog Number 1D2040 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer reports the device was disposed of, therefore unavailable for investigation.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 physician "applied extra pressure to the syringe to engage the cuff pilot, but was not able deflate the cuff, so had to dispose of the lma's.Alleged issue was reported as detected prior to use on patient.There was no report of patient harm.
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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.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 physician "applied extra pressure to the syringe to engage the cuff pilot, but was not able deflate the cuff, so had to dispose of the lma's.Alleged issue was reported as detected prior to use on patient.There was no report of patient harm.
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Search Alerts/Recalls
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