PROVENT SLEEP APNEA THERAPY
Received Nov 23, 2016 · Event occurred Nov 22, 2016
Report MW5066350 · MDR key 6128964
Device
Product problems
- Defective Device
Patient
61 YR
- Apnea
- Fatigue
- Apnea
- Fatigue
Narrative
Description of Event or Problem
PROVENT WAS DEFECTIVE. THE MESH CAME UNGLUED FROM THE BACKING ON BOTH NOSTRILS DURING THE NIGHT, SO THE DEVICE DID NOT WORK. ALL RESISTANCE TO BREATHING WAS LOST, LEADING TO APNEIC EPISODES AND FATIGUE THE FOLLOWING DAY. THIS HAS HAPPENED A FEW TIMES IN RECENT WEEKS. ANOTHER PROBLEM IS THAT THE PRODUCT DOESN'T STICK WELL TO THE SKIN, EVEN AFTER THOROUGHLY WASHING THE SKIN AND REMOVING ALL OIL WITH AN ALCOHOL WIPE. I NOW PUT PAPER TAPE AROUND ALL OF THE EDGES SO IT STICKS TO MY SKIN, AND THEN IT WORKS VERY WELL (EXCEPT WHEN IT MALFUNCTIONS, AS DESCRIBED ABOVE). THE COMPANY SHOULD EITHER MAKE THE PRODUCT STICK BETTER TO THE PATIENT'S SKIN OR RECOMMEND THAT PAPER TAPE BE USED TO MAKE IT STICK BETTER. BECAUSE SLEEP APNEA GREATLY INCREASES MORBIDITY AND MORTALITY, I WOULD ANTICIPATE THAT THIS WOULD SAVE A LOT OF LIVES. HAVING SAID THIS, IT'S A GREAT PRODUCT FOR THE MILLIONS OF PEOPLE WHO CAN'T USE CPAP (I COULD TOLERATE IT BUT COULDN'T FIND A MASK THAT FIT MY FACE), AS LONG AS YOU PUT PAPER TAPE AROUND THE EDGES. MY AHI WENT DOWN TO CLOSE TO 0 WITH TAPE, WHEREAS IN THE PACKING INSERT (WITHOUT USING PAPER TAPE) IT'S PRETTY HIGH.