Model Number IPN041363 |
Device Problem
Gas Output Problem (1266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "when the filter was attached during the anesthetic, we were unable to get any co2 trace.We opened a new box w ith a different batch number and this rectified the issue".The customer confirmed that "the three filters were changed for the one patient.The third filter was a different batch and was able to provide a trace." no patient harm or injury.The patient status is reported as "fine".See associated mdr #8040412-2023-00328.
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Event Description
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It was reported that "when the filter was attached during the anesthetic, we were unable to get any co2 trace.We opened a new box w ith a different batch number and this rectified the issue".The customer confirmed that "the three filters were changed for the one patient.The third filter was a different batch and was able to provide a trace." no patient harm or injury.The patient status is reported as "fine".See associated mdr #8040412-2023-00328.
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Manufacturer Narrative
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Qn#(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 probable root cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
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Search Alerts/Recalls
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