TELEFLEX MEDICAL HUDSON CO2 SAMPLING CANNULA A, 7FT 7FT, F; ANALYZER, GAS, CARBON-DIOXIDE,
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Catalog Number 2844 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Customer complaint alleges "doctors report that they are not getting correct/no etco2 readings." it was reported there was no patient injury or consequence.
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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.The manufacturer (b)(4) reports "we tested the co2 readings of the reserved first sample of lot 171521, there was no abnormality.The leakage of product may cause by overflowing gluing which cause the plugging, so we will announce the staff about the issue and pay attention to the gluing, and we have set the post to 100% inspect the plugging issue.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 "doctors report that they are not getting correct/no etco2 readings." it was reported there was no patient injury or consequence.
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Search Alerts/Recalls
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