Description of Event or Problem · 0
I HAVE A PHILIPS RESPIRONICS SYSTEM ONE (REMSTAR PRO C FLEX+ SN (B)(4)) CPAP WHICH IS ON THE RECALL LIST. I REPORTED THIS TO PHILIPS ON (B)(6) 2021. HAVING HEARD NOTHING FROM PHILIPS RELATIVE TO A REPLACEMENT, I CALLED PHILIPS SEVERAL MONTHS AGO AND REPORTED THAT I HAVE SEVERE APNEA (APNEA INDEX OF 93 ON MY MOST RECENT TEST), COULD NOT STOP USING THE MACHINE, AND NEEDED A REPLACEMENT ASAP. THE PERSON I SPOKE WITH SAID I WOULD BE GIVEN "HIGH PRIORITY". I HAVE NOT HEARD ANOTHER WORD ABOUT REPLACEMENT SINCE THEN. THE PEOPLE ANSWERING CALLS FOR PHILIPS ARE NO BETTER THAN AN ANSWERING SERVICE AS THEY SAY THEY HAVE NO ACCESS TO PATIENT SPECIFIC INFORMATION AND CANNOT INFORM ME WHEN MY MACHINE WILL BE REPLACED. THE SAME RESPONSE FOR 13 MONTHS NOW. YOUR OWN WEBSITE SAYS THAT PHILIPS HAS NOT COMPLIED WITH INFORMATION REQUESTS FROM THE FDA. IT IS UNBELIEVABLE TO ME THAT IN ALL THIS TIME, THE FDA HAS NOT STEPPED IN TO MAKE THIS RECALL AN "OFFICIAL" ONE AND TO FORCE PHILIPS TO BOTH PUBLICLY DISCLOSE THEIR SCHEDULE FOR REPLACING THE DEFECTIVE MACHINES AND TO MAKE PATIENT SPECIFIC INFORMATION AVAILABLE TO THOSE OF US WHO ARE WAITING FOR A REPLACEMENT. KNOWING THE SEVERITY OF MY APNEA, I WAS NOT STUPID ENOUGH TO DISCONTINUE USE OF THE DEFECTIVE MACHINE AS PHILIPS ADVISED ("MEDICAL MALPRACTICE"?). HOWEVER, I WAS FORCED TO MAKE THE CHOICE BETWEEN POTENTIALLY HAVING A HEART ATTACK OR STROKE SHORT TERM OR DEVELOPING A PULMONARY DISEASE OR CANCER LONGER TERM. WITH A FEDERAL AGENCY IN PLACE TO PROTECT CONSUMERS FROM THIS KIND OF CATASTROPHE, THERE IS NO REASON I CAN IMAGINE THAT A SITUATION WITH SERIOUS MEDICAL CONSEQUENCES FOR MANY OF US AND WITH NO RESOLUTION IN SIGHT, HAS NOT BEEN ADDRESSED IN AN AGGRESSIVE MANNER. I WOULD BE VERY INTERESTED TO HEAR YOUR REASONING AND YOUR EXPLANATION AS TO WHY MY HEALTH IS INCONSEQUENTIAL TO YOUR AGENCY. FDA SAFETY REPORT ID# (B)(4).