Philips Dreamwear Nasal Cushion-Manufacture Issues

[ElusiveSleep]

I had been using Medium size nasal cushions (Respironics, Lot# 200413, made in China) provided my DME. I needed to replace the cushion, but In the meantime I received a replacement mask “kit” (Respironics, Made in Costa Rica) containing a frame and nasal cushion, so I removed the latter and used that.

To my surprise, although a Medium, the cushion felt a little tighter around the nose, and the leak rate was far lower than with the previous China lot.

These are the readings:

Night#/95% Leak Rate
====================
Week of May 9 (China lot):
1/22
2/25
3/20
4/19
5/19
6/18

Week of May 16 (Costa Rica lot):
1/3.6
2/28
3/8.4
4/11
5/13

The cushions are obviously dissimilar as show in the photo.


I provided these details to Philips Patient Support and they said the issue would be investigated further.

Also considering reporting this to the FDA through their public complaint system, MedWatch, as this appears to be a Medical Device manufacturing quality control problem.

[clownbell]

Interesting. The photo seems to show that the Costa Rica version is more sharply curved than the China version. I have been using what appears to be the China version and have experienced large leaks with it. Maybe I can find the Costa Rica version on Amazon, where the prices are so great.

[ElusiveSleep]

It is very difficult to find the origin of the Dreamwear cushions on most online sites. The only company where I saw this info was Direct Home Medical. Calling the vendors does not really help since the customer reps seem not to have access to product specifications.

For whatever reason, Philips has sited manufacture of the multi-part mask "kits" in Costa Rica. I had previously ordered a Dreamwear full-face mask (which I only wore one night). Just checked the package - and yes - that one was also made in Costa Rica.

[GrumpyHere]

There is a medium wide size (MW) for these cushions.

It's still a QA problem, but could it be that a MW lot was mislabeled as M?

[ElusiveSleep]

I have a MW cushion (came as part of a complete mask set), and it is larger than both M size lots. So it does appear to be a manufacture inconsistency