Catalog Number 1613 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/22/2020 |
Event Type
malfunction
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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 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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Customer complaint reported as: "something has changed with this circuit and the expiratory side does not fit as tightly on the ventilator as it did before.It will actually pop off if we are not careful (and even if we are careful)." it was reported the product was not in use during a medical procedure and there was no patient complication or injury.
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Event Description
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Customer complaint reported as: "something has changed with this circuit and the expiratory side does not fit as tightly on the ventilator as it did before.It will actually pop off if we are not careful.(and even if we are careful)" it was reported the product was not in use during a medical procedure and there was no patient complication or injury.
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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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Search Alerts/Recalls
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