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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 03/12/2024 |
Event Type
malfunction
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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, and that it also measured lower peep (positive end expiratory pressure) than set and its exhaled tidal volume (vte) levels were low.There were no reports of patient involvement associated with the reported event.
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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 issues of it displaying a patient circuit disconnect alarm, as well as measuring lower peep than set and low vte levels 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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Search Alerts/Recalls
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