Model Number IPN922810 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
Event Type
malfunction
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Event Description
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It was reported that "the doctor found cuff leakage when using on patient.Then changed new one, no impact on patient".The patient status is reported as "fine".
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Manufacturer Narrative
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(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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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 "the doctor found cuff leakage when using on patient.Then changed new one, no impact on patient".The patient status is reported as "fine".
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Search Alerts/Recalls
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