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Model Number PRT-01185-002 |
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 10/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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H6: the device was evaluated by ventec where the reported issues of it providing low fio2 (fraction of inspired oxygen) readings, delivering lower peep (positive end expiratory pressure) than set and displaying a patient circuit disconnect alarm were all confirmed.Ventec replaced the internal flow transducer (ift) to resolve the reported issues.Proper device operation was then observed through functional and performance testing.The investigation determined that the cause of the reported issues was the lift.
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Event Description
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It was reported that the device needed service.During the device's evaluation, ventec observed that it was providing low fio2 (fraction of inspired oxygen) readings, delivering lower peep (positive end expiratory pressure) than set and that it displayed 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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