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Model Number LTV 1150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Loss of consciousness (2418)
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Event Date 05/09/2017 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).At this time, the evaluation has not been completed yet.Once completed, a follow-up medwatch report will be submitted.
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Event Description
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It was reported to carefusion that the patient was found unresponsive while on a ltv ventilator.The ambulance was called and the patient was transported to the hospital.The patient passed away at the hospital.There are no allegations against the ventilator, but the customer would like the unit evaluated to ensure the unit was working as intended.
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Event Description
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It was reported to carefusion that the nurse attending to the patient had informed the parents that their child was not breathing.The mother believes that by the way her child looked, he had not been breathing for some time.The mother did not hear any alarms and the nurse did not perform cpr.The paramedics were call and arrived within 10 minutes, but the patient was dead by the time they arrived.
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Manufacturer Narrative
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Device evaluation: this unit is currently being quarantined by the customer, per request; vyaire medical performed a non-invasive investigation on the unit.There was no evidence of physical damage, all parts were in place except the ventilator¿s fan guard, however, the foam fan filter was in place.An event trace log was downloaded from the unit.There were no unusual alarms present in the event trace log, all entries were consistent with normal ventilation function.
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Search Alerts/Recalls
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