Model Number LTV 1150 |
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 06/01/2020 |
Event Type
Death
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Manufacturer Narrative
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The equipment was received in vyaire facility and placed on extended testing/run-in.No root cause has been determined at this time, since the 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 passed away while on the ltv 1150 ventilator last (b)(6) 2019 and they want to send it in for evaluation.There are no allegations being made that the patient's death was caused by the unit.The patient has tracheostomy and the setting of the vent was simv, rr15 vt/0 ps18 peep +5 high pressure alarm 60 low pressure alarm 2.
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Manufacturer Narrative
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Result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.Bench testing was performed and the vent passed extended tests at customer settings with no abnormalities.Flow performance and tidal volume failed for non conformance.These slight non-conformance would not result in a failure to ventilate properly.Review of the event trace revealed that the ventilator behaved as designed and the various alarm codes observed are considered normal operation.
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Search Alerts/Recalls
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