[78296794]
I received a cpap amara view mask from (b)(6) on (b)(6). When trying to wear the mask at home, i noticed that the mask cushion was marked as size large (as was the mask packaging) but the actual cushion was size smaller than large (guessing medium). I have been wearing this mask for a while so i know how the large mask cushion feels and fits and knew right away that this cushion was too small. I further compared it to a large mask cushion that i had from an older mask and immediately could see the size difference. I contacted philips respironics and they said that they could note this and there was nothing else they could do. I contacted the sleep center who overnighted me a replacement large amara view mask size large as i am on vacation and this was the only mask that i had brought with me... The large mask cushion that i had used for comparison of size was well over 30 days old and did not have 10 days of use available for the duration of my vacation. The mask that the sleep center sent me was from the same lot and reference number as the subject original mask and it was also found to have the smaller improperly labeled mask cushion. I once again took pictures and contacted philips respironics about the issue. This issue caused me to have to cash pay to order a large replacement cushion and have it expedited to me on vacation to get through my time away. I don't presently have a dme provider as i am in between providers which is why i had to have the repeat sleep study. So my only option was to cash pay to get a cushion so that i could use the mask. The cushion i cash paid was made and labeled properly and i was able to wear it with no problem. I provided additional pictures to philips respironics after receiving the replacement cushion. Having spent most of my working career in the pharmaceutical/medical device industry, i know that this is a critical issue, and wanted to properly report it to fda as well. Mask is lot 61478581, reference number (b)(4).
Patient Sequence No: 1, Text Type: D, B5