[178002644]
To clarify one point, i am a physician. However, i am reporting as a pt because i was the pt in this case. I began using a respironics "dreamstation" cpap machine in (b)(6) 2019, set to the auto cpap mode with an initial pressure range of 5 to 15 cm h2o. At some point, i noticed that the pressures were high much of the time. This created a problem with increasing mask leak and poor sleep due to discomfort from the higher pressures. In (b)(6) 2020, i realized the problem: a defective machine. On the night of (b)(6) 2020, i was lying in bed, fully awake, with the mask on, and i noted the pressure on the machine increasing from 5 to 10 then to 15 as i lay there awake, breathing normally. Over the next few days, i tried several maneuvers to test the machine. For example, i unplugged it, plugged it back in to reset it, and then i sat upright with the mask on, breathing normally. The pressure increased over 5 or 10 mins. I also confirmed similar machine performance on data uploaded from the machine to (b)(6) software on my pc; it appeared to be sensing multiple vibratory snores while i was sitting up awake. I brought the machine to my dme provider, who confirmed that it was broken. I have had no problems with the replacement machine over the last two weeks. Of note, my dme provider recently informed me that she fitted another stent with a new machine, and, in her words, "i had another machine, brand new out off the box, increasing the pressure as we were sitting in the office. " you could contact my provider, (b)(6) for info about the other machine. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5