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Model Number IPN913994 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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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It was reported that: "after a week of use, the o2 flow is no longer delivered.It makes noise.By removing the white filter, the flow returns to normal".No patient injury or harm reported.Patient condition unknown at time of report.Request for additional information has been unsuccessful.
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Search Alerts/Recalls
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