I own a philips dreamstation bipap machine.Philips sent a replacement for the defective part last year and i replaced it.The current machine is working less predictably.But when i attempt to replace the machine i'm informed by medicare, and my insurer and my doctor and the supplier that i cannot purchase a new bipap machine because the fda has mandated that i pass a sleep test that i cannot possibly pass because i cannot sleep without a bipap machine.The fact that my machine is more than five years old and therefore due replacement is irrelevant to the fda.I've tried contacting the fda by phone but no one responds.When i leave a message with the fda, no one responds.When i attempt to determine the specific fda official responsible for withholding a bipap machine replacement, their identity is withheld by the fda.Up until now philips has provided me with a machine that has kept me living the past 16 years.Conversely the fda has abused its authority by preventing the acquisition of a new bipap machine.In other words, the fda actions threaten my life.Model, catalog, lot, serial, and udi numbers: i am blind and i cannot read.The apparent gross indifference by the fda has created needless anxiety.The fda, not philips, threatens my health and even my life.Thus far the fda exhibits complete indifference.Fda safety report id # (b)(4).
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