Model Number LTV 1150 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/28/2021 |
Event Type
Death
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Manufacturer Narrative
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81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, the customer sent the event trace for review.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 to vyaire medical that a patient passed away while connected to the lap top ventilator 1150.At this time, no information is available regarding whether or not the device had anything to do with the patient's passing.
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Manufacturer Narrative
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Result of investigation: analysis of the event trace was performed.No physical analysis of the vent was done.The event trace show a continuous self reset due to a loss of an external power source causing the vent to continuously attempt to power on the vent.The issues found within the event trace indicated an unstable power source or lack thereof.
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Search Alerts/Recalls
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