Model Number LTV 1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 02/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The ventilator was received in house at the carefusion facility in (b)(4).For evaluation.The unit was placed on tests and event trace is being reviewed.No root cause has been determined yet since investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported that a patient involved with ltv 1200 passed away mainly because of the patient's condition.It was also reported that during the time of death, the patient was not connected to the ventilator.
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Manufacturer Narrative
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Result of investigation: vyaire medical failure analysis laboratory investigation revealed that the suspect device function normally for the settings provided.Unit passed 108 hours extended tests at run-in settings.However, unit failed troubleshooting final test at pressure and oxygen blending performance.
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Search Alerts/Recalls
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