The patient was traveling with family from (b)(6).Five hours into their drive, the unit (s/n (b)(4)) failed with a low oxygen purity alarm.The patient received a replacement unit the next day from their distributor; however, this unit had a total power failure, and the patient had to be admitted to the hospital.The patient is a tracheotomy patient using 3 lpm.The patient received alternate oxygen, and made it back home using oxygen tanks.
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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 unit was returned for an evaluation.The root cause of the low oxygen alarm was identified to be a stalling motor within atf assembly.A torque test revealed that the motor produced insufficient torque to drive the assembly and thus kept stalling.The motor, which drives the atf's rotary valve, disrupted the assembly's valve timing and thus affected the vpsa cycle that eclipse 5 uses to concentrate oxygen.This would cause fluctuations in the unit's output purity.
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