Model Number IPN044386 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/05/2023 |
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 the "filters on either side of the artificial noses for tracheostomy patients were full with secretions and fell off.When patients cough, the filters also fall down".As a result, the device was changed out for another.No patient harm or injury.
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Event Description
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It was reported that the "filters on either side of the artificial noses for tracheostomy patients were full with secretions and fell off.When patients cough, the filters also fall down".As a result, the device was changed out for another.No patient harm or injury.
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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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Search Alerts/Recalls
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