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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 10/02/2023 |
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 authorized service provider (asp) where the reported issues of it displaying a patient circuit disconnect alarm, its peep (positive end expiratory pressure) being unstable (low) and having low exhaled tidal volume (vte) levels, as well as an unexpected breath rate were all confirmed.The asp replaced the external flow module (efm) and internal flow transducer (ift) to resolve the reported issues.Proper device operation was observed through functional and performance testing.The investigation determined that the cause of the reported issues was the efm and 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's peep (positive end expiratory pressure) was unstable (low) and that its exhaled tidal volume (vte) levels were low.In addition, the asp observed that the device was providing an unexpected breath rate and that it would display 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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