Description of Event or Problem · 0
MY HUSBAND AND I BOTH USE SEPARATE SOCLEAN2 DEVICES FOR CLEANING OUR RESMED CPAP EQUIPMENT. WE BOTH PURCHASED THEM AROUND (B)(6) 2018 AND HAVE BEEN USING DAILY EVER SINCE. WE WERE NOT AWARE OF THE RECALL OF THE (B)(4) DEVICES. I DISCOVERED THIS WHILE SEARCHING ONLINE FOR A NEW TOP FOR THE WATER CHAMBER ON MY HUSBAND'S RESMED CPAP MACHINE. I KEPT NOTICING THAT HE HAD DARK SPECKS IN HIS WATER CHAMBER AFTER USING OVERNIGHT. DAILY THE CHAMBER WAS EMPTIED AND NEW WATER ADDED BEFORE RUNNING THROUGH THE SOCLEAN 2 CLEANING CYCLE. HIS RESMED AIRFIR F20 FULL FACE MASK WAS ALSO ADDED AT THE SAME TIME TO THE SOCLEAN 2 CYCLE. THIS RESMED MASK HAS TWO BLUE CIRCULAR DOTS FOR CONNECTING THE HEADGEAR AND TWO SQUARE BLUE PIECES ON THE FRAME. AM WONDERING IF THE SOCLEAN 2 WAS CAUSING SOME TYPE OF BREAKDOWN DURING THE CLEANING CYCLE. I DID NOT NOTICE THIS TYPE OF MATERIAL IN MY RESMED WATER CHAMBER AS I HAVE A DIFFERENT TYPE MASK. AS A SIDE NOTE, THE WATER IN MY HUSBAND'S WATER CHAMBER HAS BEEN CLEAR FOR THE PAST TWO MORNINGS POST DISCONNECTING OF THE SOCLEAN 2 DEVICE. AS OF (B)(6) 2024 WE NO LONGER USE THE SOCLEAN 2 DEVICES AND HAVE DISCONNECTED THEM. I HAVE REVIEWED SOME OF THE INFORMATION ON THE INTERNET REGARDING THE MEDICAL ISSUES REPORTED BY THOSE WHO WERE USING THIS DEVICE, AND MY HUSBAND AND I BOTH AGREE THAT USE OF THIS DEVICE MAY EXPLAIN SOME OF THE VAGUE HEALTH ISSUES THAT WE HAVE BEEN EXPERIENCING SUCH AS CHRONIC HEADACHES AND GENERAL FEELING OF NOT FEELING WELL. WE HOPE THAT THIS INFORMATION HELPS WITH THE ONGOING REVIEW OF THESE DEVICES. REFERENCE REPORTS: MW5154692, MW5154693.