Model Number VISIONAIRE |
Device Problems
Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 01/24/2016 |
Event Type
Death
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Manufacturer Narrative
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The unit is being kept at the facility where the incident occurred until the manufacturer, provider, nursing home and attorney can supply expert witnesses to attend.Once a date is selected, the testing of the unit will commence.
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Event Description
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The company was notified on (b)(4) 2016 of an event that occurred on (b)(6) 2016 involving a visionaire oxygen concentrator.The unit was present at the scene of a fire that resulted in the death of the patient.There is no information on the cause of the fire.
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Manufacturer Narrative
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The provider inspected the unit but the company was not included in the inspection.The results were communicated to the company after the inspection.There was debris taken from the scene that included smoking materials including an ashtray, remnants of an e-cigarette, and other items.The inspection showed that there was nothing wrong with the concentrator.The fire originated at the patient end of the cannula and moved toward the concentrator.The unit explicitly states that there should be no smoking while using the unit or around the unit.
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Event Description
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The company was notified on february 3, 2016 of an event that occurred on (b)(6) 2016 involving a visionaire oxygen concentrator.The unit was present at the scene of a fire that resulted in the death of the patient.There is no information on the cause of the fire.
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Search Alerts/Recalls
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