Description of Event or Problem · 0
I'M REPORTING ON A BIPAP MACHINE FROM RESVENT IBREEZE BPAP SYSTEM MODEL: IBREEZE 25STA. I BELIEVE IT'S FDA APPROVED FOR EMERGENCY USE THANKS TO THE PANDEMIC AND SEEKING CLEARANCE. PLEASE DO NOT APPROVE THIS PRODUCT AND I BELIEVE IT'S A DANGER TO EVERY PERSON WHO HAS TO USE IT. REVIEWS ONLINE SAY EVERYTHING THAT I'M ABOUT TO SAY. I TESTED THE MACHINE TO KNOW WHAT TO EXPECT FROM IT. DIDN'T LIKE IT BUT ASSUMED I'D GET USE TO IT. FIRST NIGHT I ATTEMPTED TO SLEEP WITHOUT IT, I LAID THERE WIDE AWAKE (WHILE RAMP MODE WAS ON, ON THE MACHINE TO EASE ME INTO IT) STRUGGLING TO GET AIR IT SEEMED EVERY OTHER BREATH. I COULDN'T EXHALE BEFORE A FORCE OF AIR WOULD COME THROUGH. IT WAS ALL VERY IRREGULAR. HAD ME BREATHING TOO FAST. AT TIMES, I COULDN'T EVEN TAKE A BREATH AS THE MACHINE SEEMED TO STOP WORKING. AFTER 39 MINUTES OF THIS, MY PULSE OXIMETER ALARM WENT OFF SAYING MY O2 HAD DROPPED TO 81 AND WAS STEADILY DROPPING. I PUT MY SUPPLEMENTAL OXYGEN ON INSTEAD AND LEFT THE MACHINE OFF FOR THE NIGHT. I DID A FEW MORE TESTS OF THE DEVICE AND RECREATED APNEAS. WHEN IT WOULD PULL MY BREATH OUT, THERE WERE TIMES IT WOULDN'T PUSH AIR BACK IN FOR UP TO 64 SECONDS. I COULDN'T HOLD MY BREATH ANY LONGER AFTER EXHALING OR IT MIGHT NOT HAVE PUSHED AIR AT ALL. THE OTHER TIMES ALL VARIED WITH THE LEAST AMOUNT OF TIME BEING 15 SECONDS AND MOST OTHERS WERE BETWEEN 35-45 SECONDS. I STRUGGLED TO PULL AIR FROM THE MACHINE SO I COULD BREATHE WHILE I WAS SITTING ON BEDSIDE. IT WAS STRAINING MY LUNGS TO A DANGEROUS EXTENT TO GET THE MACHINE TO FINALLY GIVE ME A PUFF OF AIR BEFORE PULLING THE BREATH BACK OUT. HAD I NOT HAD ON MY PERSONAL MEDICAL GRADE PULSE OX THAT FIRST NIGHT, WHO KNOWS WHAT WOULD HAVE HAPPENED TO ME. WAKING UP GASPING FROM A MACHINE MEANT TO HELP YOU BREATHE IS AN AWFUL FEELING. I BEG OF YOU TO PLEASE REMOVE THIS FROM OUR MARKET IN THE US! PEOPLE WOULD BE BETTER OFF DURING COVID INTERVENTIONS NOT USING THIS MACHINE, AS I CAN ONLY SEE IT CREATING WORSE MEDICAL PROBLEMS AND EVEN DEATH. IT ALSO SMELLS LIKE BURNING PLASTIC THROUGH THE MASK PILLOWS AS WELL AS IN THE ROOM IT'S IN. THIS COULD BE DUE TO IT BEING A NEW MACHINE OR ALSO SOMETHING FAULTY BURNING INSIDE IT. EITHER WAY, IT'S STILL WORTH MENTIONING AS THIS IS GOING IN OUR LUNGS. I STILL HAVE THE PRODUCT AT THE MOMENT BUT SENDING IT BACK TO BE REPLACED BY THE LUNA BY 3B WHICH I HOPE IS BETTER! I GOT MY MACHINE VIA (B)(4). THEY'RE ALSO THE ONE'S SENDING THE LUNA. FDA SAFETY REPORT ID# (B)(4).