Model Number PRT-01184-000 |
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 06/23/2023 |
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 ventilator measured lower peep (positive end expiratory pressure) than set and that its exhaled tidal volume (vte) levels were low.In addition, the device's breath rate was not as expected (low) and it displayed a "patient circuit disconnect" alarm.There were no reports of patient involvement associated with the reported event.
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Manufacturer Narrative
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H6: the authorized third party service provider (asp) will further evaluate and repair the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.H3 other text : to be serviced by 3rd party.
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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 lower peep (positive end expiratory pressure) than set, low exhaled tidal volume (vte) levels, an unexpected breath rate (low) and providing 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 observed through functional and performance testing.The investigation determined that the cause of the reported issues was the ift.
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Search Alerts/Recalls
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