RESPIRONICS

Description of Event or Problem

VENDOR OF EQUIPMENT WAS TELLING VARIOUS INFO ABOUT THE RESPIRONICS COMFORTGEL MASK REGARDING MFR'S DEFECTS - CLIPS THAT HOLD STRAP CONSTANTLY FAIL AND MAKE MASK UNUSABLE. THE VENDOR RELUCTANTLY REPLACED THE DEFECTIVE MASK. WE WERE ALSO TOLD THAT IT WOULD NOT BE COVERED BY INSURANCE AND LATER TOLD, IT WOULD BE AFTER THE DEFECT WAS KNOWN. THE VENDOR APRIA HEALTHCARE IS NOT RESPONDING CORRECTLY TO A 'KNOWN' DEFECT AND SEVERAL REPS FROM APRIA LATER DENIED THERE WAS A PROBLEM WITH THE MASK. AFTER RESEARCH ON THE FDA SITE, WE FOUND THAT RESPIRONICS HAS HAD SOME PROBLEMS RELATED TO THIS MASK IN THE PAST THIS SEEMS TO BE A NEW PROBLEM AND IS NOT BEING CAUGHT BY THE PLANT THAT MAKES THEM IN ANOTHER COUNTRY, OR THE RECEIVING QC DEPT. THAT HANDLES INCOMING PRODUCTS. WHILE THIS IS NOT A LIFE THREATENING SITUATION, THERE SEEMS TO BE A POSSIBILITY THAT QC IS NOT FOLLOWING DESIGN AND MATERIAL REQUIREMENTS GIVEN BY THE FDA FOR SUCH MEDICAL EQUIPMENT. DIAGNOSIS OR REASON FOR USE: SLEEP APNEA.