Caire is contacting the initial reporter of the incident ((b)(6)) to gather more information about the incident, and well as to coordinate the return of the units for an evaluation, if possible.The three devices (2 liberators, 1 stroller) present at the scene of the incident are currently in police custody.If any new information is discovered, a follow-up report will be submitted.
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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.Two of the three devices present at the scene of the incident were returned to caire for an evaluation.The liberator (s/n (b)(6)) is in police custody and was not returned to caire.The evaluation, conducted by caire personnel, of the returned liberator 45 stationary liquid oxygen reservoir (s/n (b)(6)) and stroller liquid oxygen portable unit (s/n (b)(6)) could not find the root cause of the adverse event.Both the reservoir and the portable unit sustained substantial fire damage and were deemed non-functional and not suitable for any functional testing.Only a visual inspection of the test units could be conducted.A separate investigation conducted by austrian authorities stated that the fire was due user negligence.They specified that the fire was very likely the result of smoking in conjunction with the use of medicated oxygen.
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