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Model Number AS098-4 |
Device Problem
Environmental Particulates (2930)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The unit has been returned for evaluation.If any new information is discovered, a followup report will be submitted.
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Event Description
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Unit was at a nursing home.The unit was plugged in a resident's room and then turned on.The unit was left running while nurses left the room, they later came back and claimed that there was smoke in the room and the unit was hot.(b)(6) picked up the unit from the nursing home and had his tech department run the unit for a day and a half.After testing, they claimed there was no smoke coming from the unit, no burning smell, and that the unit was not hot.They could not recreate any issues and claim the unit is fine.(b)(6) tried to take the unit back to the nursing home, but they refuse to use the unit afterwards.
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Event Description
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This report was originally submitted on 10/17/2018, and is being resubmitted on 4/8/2020 as the original submission failed to go through.
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Manufacturer Narrative
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"pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein." the burning smell or the smoke described by the nurses could not be replicated through outtesting the concentrator unit.Inspection of the unit's casing and its internal components discovered no damage or signs of fire.The concentrator performed well within its functional specifications, and it did not behave abnormally during extended periods of use.
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Search Alerts/Recalls
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