Description of Event or Problem · 0
PHILIPS RESPIRONICS FULL CUSHION FOR CPAP. PACKAGE INFO SAYS REF 1133432, LOT 0303576101, CR 2025-09-16, PN 300011312731. THE WHITE PLASTIC PART THAT GOES THROUGH THE CLEAR HARD PLASTIC MOUTH COVER HAS MASSIVE AIR LEAK NEW OUT OF PACKAGE AND IS UNUSABLE. THE OUTSIDE OF THIS WHITE PART IS WHERE THE MAGNET ON THE HEAD STRAP CONNECTS TO THE MOUTHPIECE WHEN IN USE. I HAVE USED THIS MODEL OF THE ITEM FOR SEVERAL YEARS AND REPLACE IT NEW MONTHLY. APPROXIMATELY EVERY 10 OR SO UNITS HAS THIS DEFECT AND HAS FOR AS LONG AS I HAVE PURCHASED THEM. ALSO, EVEN WHEN NOT A MASSIVE LEAK, THERE WILL BE A SMALL LEAK WHERE THE STRAP MAGNET CONNECTS TO THE CUSHION AND WILL CAUSE A HISS AND OR WHISTLE THAT WILL WAKE THE USER. THIS IS AN ONGOING PROBLEM FOR MANY YEARS AND I ASK THAT THE FDA INVESTIGATE THIS AND TAKE APPROPRIATE ACTION TO CORRECT THIS ISSUE AND REQUIRE ONGOING MONITORING BY THE MAKER OF THIS ITEM. THE DME PROVIDERS ALWAYS DEMAND THAT THE DEFECTIVE UNITS BE RETURNED FOR REPLACEMENT AND AM THEREFORE UNABLE TO PROVIDE THE UNIT TO THE FDA. ONE NOTE ALSO IS THAT DIFFERENT DME PROVIDERS SEEM TO HAVE HIGHER DEFECT RATES THAT MAKES ME QUESTION IF THEY MAY BE USING COUNTERFEIT PRODUCTS. THE CURRENT PRODUCT WAS OBTAINED FROM (B)(6). BUT I HAVE RECEIVED UNITS WITH THE SAME DEFECT FROM SEVERAL OTHER DME SUPPLIERS OVER THE YEARS.