PURESOM - ADJUSTABLE RUBY CHIN STRAP

Additional Manufacturer Narrative

(B)(4). THE COMPLAINT DEVICE WAS RECEIVED BY CAREFUSION AND SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION. WHEN USED PROPERLY PER THE USE INSTRUCTIONS, THE CHINSTRAP IS APPLIED PRIOR TO THE CPAP MASK/HEADGEAR ASSEMBLY. THE CHINSTRAP IS UTILIZED TO HELP THE USER KEEP THEIR MOUTH CLOSED WHILE SLEEPING. THE CHINSTRAP INSTRUCTIONS INDICATE THAT THE CHINSTRAP SHOULD BE APPLIED PRIOR TO THE MASK/HEADGEAR ASSEMBLY. FAILURE OF THE CHINSTRAP SHOULD NOT IMPACT USE OF THE CPAP MASK/HEADGEAR ASSEMBLY. EVEN WITH A BROKEN CHINSTRAP THE MASK SHOULD REMAIN IN PLACE AND SUFFICIENT OXYGEN SHOULD CONTINUE TO BE DELIVERED TO THE PATIENT FROM THE CPAP MACHINE. AN INVESTIGATION WAS PERFORMED BY CAREFUSION INTO THE CUSTOMER¿S REPORTED ISSUE OF THE VELCRO TAB COMING OFF OF THE CHINSTRAP DURING USE. THE VELCRO TABS ARE ULTRASONIC WELDED ONTO THE CHINSTRAP DURING MANUFACTURE OF THE DEVICE. A PULL TEST IS PERFORMED ON THE VELCRO TAB FOLLOW THE ULTRASONIC WELDING PROCESS. HOWEVER, IT WAS CONFIRMED THAT A PEEL TEST IS NOT CONDUCTED. AN ENGINEERING STUDY WAS PERFORMED TO CHALLENGE THE PEEL RESISTANCE OF THE VELCRO TABS ON THE CHIN STRAPS. THE RESULTS CONFIRMED THAT EVEN THOUGH THE DEVICES ARE PASSING THE PULL TESTING, THE PEEL TESTING HAD VERY LOW VALUES WITH SOME FAILURES. THE WELDING PROCESS PARAMETERS (WELD ENERGY, WELD PRESSURE, AND HOLD TIME) WILL BE REVALIDATED TO ENSURE THAT PEEL AND PULL TEST REQUIREMENTS ARE ACCEPTABLE. IN ADDITION, BOTH PEEL AND PULL TEST REQUIREMENTS WILL BE IMPLEMENTED. (B)(4).

Additional Manufacturer Narrative

(B)(4). THE COMPLAINT DEVICE HAS BEEN RECEIVED BY CAREFUSION AND SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION. THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED. (B)(4).

Description of Event or Problem

CUSTOMER REPORTED THE FOLLOWING TO CAREFUSION: VELCRO TAB CAME OFF CHINSTRAP AFTER ABOUT 2 MONTHS OF USE. ADDITIONAL INFORMATION RECEIVED BY CAREFUSION FROM THE CUSTOMER ON (B)(6) 2016: ¿I HAVE BEEN A CPAP USER SINCE 2005. MY BIGGEST PROBLEM HAS ALWAYS BEEN KEEPING MY JAW CLOSED DURING CPAP USE. I WAS THRILLED TO FIND YOUR CHIN STRAP WHICH ALWAYS WORKED AND KEPT ME BREATHING NORMALLY WITH MY CPAP MACHINE. I ALWAYS WAKE UP REFRESHED. I KNOW ABOUT BREATHING IMPACT, AS WHEN THE CHIN STRAP IS TO TIGHT, I WOULD END UP WITH A HEADACHE FROM THE STRAP. ALSO IF THE CHIN STRAP WAS TOO LOOSE, I WOULD SNORE WITH MY MOUTH OPEN WHICH WOULD INTERFERE WITH THE PROPER FUNCTIONING OF THE CPAP. I WOULD WAKE WITH A HEADACHE AND A DRY MOUTH/THROAT AND TIRED. I KNOW THE DIFFERENCE BETWEEN THE 2 DIFFERENT HEADACHES CAUSED BY THESE TWO FAILURES. THE MORNING I WORK UP WITH THE FAILED CHIN STRAP, IT WAS APPARENT THAT HEADACHE WAS CAUSED BY CHIN STRAP BEING TORN AS I HAD A DRY MOUTH. MY HEADACHE WAS CAUSED BY MY BRAIN NOT RECEIVING SUFFICIENT OXYGEN FROM THE CPAP MACHINE OVER THE NIGHT. BREATHING NORMALLY MAKES THE HEADACHE GO AWAY. I DO NOT KNOW WHY YOU STICKY-BACK TORE. I TRIED TO PLACE THE TAPE BACK ON THE CHIN STRAP, AND USED IT THE NEXT DAY. HOWEVER, THE SAME THING HAPPENED THE NEXT DAY (HEADACHE AND DRY MOUTH/THROAT, TIRED) AS THE TAPE DID NOT HOLD, BUT FELL OFF AGAIN. I AM NOW USING AN OLD CHINSTRAP. AS CHIN STRAPS ARE ONLY ALLOWED TO BE REPLENISHED EVERY 6 MONTH BY (B)(6). I AM ON MY 8TH MONTH OF USE OF THE OLDER CHINSTRAP. IF THE CHIN STRAP IS NOT GOING TO LACK 6 MONTHS, YOU NEED TO CONVINCE MEDICARE THAT CHIN STRAPS SHOULD BE REPLENISHED EVERY 3 OR 4 MONTHS. AS A REQUEST, IS IT POSSIBLE YOU CAN SEND ME A REPLACEMENT CHIN STRAP ¿AS SOON AS POSSIBLE.¿ MY CHIN STRAP IS THE WEAKEST LINK IN THE CHAIN¿ RIGHT NOW AND I RELY UPON ITS STABILITY TO GET ME THROUGH THE NIGHT¿.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF MDR SUBMISSIONS. ADDITIONAL INFORMATION HAS BEEN COMPLETED.