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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn(s) (1757)
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Event Date 05/26/2020 |
Event Type
Injury
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Event Description
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The manufacturer received a voluntary medwatch, (b)(4), that alleged a patient was smoking while an oxygen concentrator was in use.The oxygen tubing caught on fire.The patient sustained 2nd degree burns to their thigh and refused medical treatment.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.
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Manufacturer Narrative
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The manufacturer previously reported a patient was allegedly smoking a cigarette while using an everflo oxygen concentrator.The oxygen tubing caught on fire.The patient sustained 2nd degree burns to their thigh and refused medical treatment.The devcie was returned to the durable medical equipment supplier (dme).The device was tested at the dme and found the device to operate to design specifications.The device was placed back in service.Product labeling states,"oxygen vigorously accelerates combustion and should be kept away from heat or open flame.Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.Do not smoke, allow others to smoke or have open flames near the concentrator when it is in use.".
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Search Alerts/Recalls
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