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Model Number PRT-01185-000 |
Device Problems
Inaccurate Delivery (2339); 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 11/08/2023 |
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 further evaluated by the asp where the reported issues of it measuring lower peep than set, low vte and vti 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 ventilator measured lower peep (positive end expiratory pressure) than set, low vte (exhaled tidal volume) and low vti (inspiratory tidal volume) levels.It was also 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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