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Model Number PRT-01185-000 |
Device Problems
Connection Problem (2900); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H6: the device was not returned to ventec for evaluation.The device was evaluated by an authorized service provider (asp) where the reported issues of it providing low fio2 (fraction of inspired oxygen) readings, low exhaled tidal volume (vte) levels and displaying a patient circuit disconnect alarm were all confirmed.The asp replaced the internal flow transducer (ift) to resolve the reported issues.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issues was the ift.H3 other text : serviced by asp.
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Event Description
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An authorized third party service provider (asp) contacted ventec to report that the device was providing low fio2 (fraction of inspired oxygen) readings, low exhaled tidal volume (vte) levels, and was displaying a patient circuit disconnect alarm.There were no reports of patient involvement associated with the reported event.
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Search Alerts/Recalls
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