Catalog Number 1770 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
Event Type
malfunction
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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.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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It was reported "we report a nebulizer, which when filling the water is broken in the basal part.Reports works briefly for a week or two, then it stops putting out mist.The pick up tube that goes into the "jar", sucks the water up and a heater/compressor should give mist into mask.Not sucking water, so no mist is reported".No patient involvement reported.
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the nebulizer jar was damaged and a piece of plastic on the bottom was broken off.Functional testing could not be performed due to the damage on the sample.Due to the condition of the returned sample , the complaint could not be confirmed and a probable cause could not be determined.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 "we report a nebulizer, which when filling the water is broken in the basal part.Reports works briefly for a week or two, then it stops putting out mist.The pick up tube that goes into the "jar", sucks the water up and a heater/compressor should give mist into mask.Not sucking water, so no mist is reported".No patient involvement reported.
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Search Alerts/Recalls
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