Description of Event or Problem · 0
I WAS USING A RESMED CPAP MACHINE, AND MY WHOLE FACE, NECK, BACK, HANDS, FEET, LEGS, AND BACK WERE ALL SWOLLEN. I STOPPED USING THEM AFTER 34 DAYS AND I WAS NOT ABLE TO BREATHE AND ENDED UP IN ER AND CT SCAN SHOWED THAT I HAD SOFT TISSUE SWELLING IN THE BACK AND ABOUT 6 MONTHS LATER CT AND MRI SCANS FROM THE HOSPITAL SHOWED THAT I HAD INFLAMMATION ALL OVER MY JOINTS. MANUFACTURING RESPONSE TO HEALTH CANADA SAYS THAT THESE INJURES AND DAMAGES TO ALL CPAP MACHINES USING SOMETIMES CAUSE SOFT TISSUE SWELLING, INFLAMMATION INJURIES, AND DAMAGE TO MUSCLES, TENDONS, AND LIGAMENTS. THESE ARE VERY SERIOUS HEALTH ISSUES AND SAFETY RISKS. I AND MY HUSBAND GOT BONE CHANGES AND BRAIN CHANGES DUE TO VERY POWERFUL AND STRONG AIR PRESSURE BLEW OUT AND THE SLEEP STUDIES DOCTOR SAID THE SLEEP STUDIES ARE 60 YEARS OLD WITH TODAY'S TECHNOLOGY DO NOT BLEND AND WORK TOGETHER AND THAT'S WHY I AND MY HUSBAND GOT INJURES AND DAMAGES TO OUR BODIES. I AND MY HUSBAND CONSISTS WITH PAIN KILLERS, ANTI-INFLAMMATORIES, AND THERAPIES BUT STILL NOT GOING AWAY. NO DIFFERENCE BETWEEN PHILIP'S DEVICES CAUSING CANCER. I AND MY HUSBAND'S INJURIES AND DAMAGE TO OUR HEALTH PROBLEMS SUFFER THE SAME AS CANCER CAUSES BECAUSE OUR BODIES ARE INJURED AND DAMAGED AND LIVE WITH PAINS, SEVERE HEADACHES AND NOT BEING ABLE TO FUNCTION OUR MOMENTS WELL. PLEASE TAKE IMMEDIATE ACTION. RESMED INC SENIOR ENGINEER QUALITY RESPONDED INAPPROPRIATELY. BACK UP FOR MANUFACTURING BENEFIT. 2 MACHINES WERE RETURNED AND ONLY ONE WAS TESTED. ON ONE HAND, RESMED LIED NOT FINDINGS AND ONLY RECEIVED ONE CPAP MACHINE TEST, BUT ON THE OTHER HAND, THEY RESPONDED TO HEALTH CANADA THAT HEALTH RISKS AND SAFETY RISKS HAVE TO CPAP MACHINE USE SOMETIMES, AND THE STORE ONLY RETURNED BOTH CPAP RESMED MACHINES TO THE MANUFACTURER SINCE FEB. 24, 2021. THEY TRY TO PUSH THE PROBLEMS AWAY AND DO NOT RESPOND PROPERLY TO ME AS THE CLIENT. PER CLINICAL OPINION, SOFT TISSUE SWELLING OR INFLAMMATION IS DAMAGE OR INJURY TO THE MUSCLES, TENDONS, AND LIGAMENTS. IT IS COMMONLY CAUSED BY EITHER ACUTE INJURY (DIRECT TRAUMA) OR OVERUSE/EXCESSIVE INJURIES OF THE INVOLVED TISSUE. SYMPTOMS INCLUDE PAIN, SWELLING, AND BRUISING. TREATMENT PLANS CONSIST OF MEDICINE (ANTI-INFLAMMATORY, PAIN KILLERS, CORTICOSTEROIDS), PHYSICAL THERAPY, AND ALSO REST. UNDER THE INTENDED OPERATING CONDITIONS OF THE DEVICE, IT IS NOT LIKELY THAT THE DEVICE AND/OR PAP THERAPY HAD CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS AS THERE IS NO DIRECT SKIN CONTACT BETWEEN THE DEVICE AND THE PATIENT'S FACE, NECK, OR BACK AREA. THE AIRSENSE 10 USER GUIDE PROVIDES THE FOLLOWING WARNING: - "PATIENTS SHOULD REPORT UNUSUAL CHEST PAIN, SEVERE HEADACHE, OR INCREASED BREATHLESSNESS TO THEIR PRESCRIBING PHYSICIAN. AN ACUTE UPPER RESPIRATORY TRACT INFECTION MAY REQUIRE TEMPORARY DISCONTINUATION OF TREATMENT". THE SAFETY RISK AND OCCURRENCE RATE WERE ASSESSED FOR EACH COMPLAINT AND DO NOT WARRANT A RECOMMENDATION TO TAKE ANY IMMEDIATE CORRECTIVE OR CONTAINMENT ACTIONS. FDA SAFETY REPORT ID# (B)(4).