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 information provided represents the best information available to caire.The device(s) will not be available for engineering evaluation.The end user reported smoking a cigarette while using the device.No smoking warnings on the equipment and in the ifu were reviewed and deemed adequate in the course of the investigation."no smoking" symbols (reg# p002) are affixed to the face of the units.Throughout the unit ifu, warnings state not to allow smoking or open flame near the device and to keep all flammable materials away from the equipment.Additional warnings state that smoking while wearing an oxygen cannula can cause facial burns and possibly result in death.
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