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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 03/11/2024 |
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 further evaluated by the authorized service provider (asp) where the reported issue of it displaying a patient circuit disconnect alarm, as well as measuring lower peep (positive end expiratory pressure) than set and low exhaled tidal volume (vte) levels were all confirmed.The asp replaced the internal flow transducer (ift) to resolve the reported issue.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue 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 displaying a patient circuit disconnect alarm, that it measured lower peep (positive end expiratory pressure) than set and that its exhaled tidal volume (vte) levels were also low.There were no reports of patient involvement associated with the reported event.
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Search Alerts/Recalls
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