Description of Event or Problem · 0
I¿M WRITING TO EXPRESS MY DISSATISFACTION WITH A FAULTY RESMED CLIMATE LINE AIR 11 WHICH I RECEIVED IN MY RECENT CPAP RESUPPLY ORDER (#S(B)(4) ORDERED AND SHIPPED ON 7/1/2024 AND RECEIVED AT MY HOME ON 7/5/2024). I¿M SEEKING AN ODOR-FREE REPLACEMENT AS WELL AS THE ASSURANCE THIS PRODUCT IS SAFE FOR PATIENTS. BOTH AEROCARE AND RESMED QUALITY CONTROL NEED TO INVESTIGATE AND TAKE THIS SERIOUSLY. IT IS VERY DIFFICULT TO BELIEVE I AM THE ONLY RECIPIENT OF A CONTAMINATED HOSE SHIPPED IN THIS EASILY IDENTIFIABLE AND CLEARLY UNACCEPTABLE CONDITION. HERE ARE THE DETAILS OF MY RECENT NEGATIVE EXPERIENCE: THE ENTIRE BOX OF SUPPLIES REEKED OF A PETROLEUM PRODUCT FROM THE MOMENT I OPENED IT, AND NOT JUST THE FAULTY HOSE ITSELF. THE HOSE, HOWEVER, IS CLEARLY THE SOURCE, AS THE ODOR GREATLY INTENSIFIED AFTER I UNWRAPPED THE SEALED CELLOPHANE BAG CONTAINING THE HOSE. IT IS NO EXAGGERATION TO SAY THAT AFTER I UNWRAPPED THE HOSE, IT SMELLED LIKE I HAD GONE TO THE GAS STATION AND SPILLED GASOLINE ON MY CLOTHING OR CAR. I WASHED THE HOSE IN A LIGHTLY SCENTED PURDOUX CPAP MASK AND HOSE SOAP, ASSUMING THAT WOULD ELIMINATE THE PUNGENT AND OFFENSIVE ODOR. INSTEAD, THE PRODUCT, REMARKABLY, CONTINUES TO SMELL STRONGLY OF PETROLEUM FOUR DAYS AFTER IT WAS WASHED, SOAKED, AND AIR DRIED. THIS PRODUCT ALSO CONTAMINATED THE OTHER SUPPLIES WITH WHICH I WASHED IT (MY EXISTING HOSES AND CPAP HUMIDAIR 11 STANDARD WATER TUB AS WELL AS THE NEW TUB INCLUDED IN THE NEW ORDER). NOW, ALL THESE PIECES HAVE AN UNPLEASANT GASOLINE ODOR AFTER BEING WASHED AND SOAKED WITH THE CONTAMINATED HOSE. I¿M ALARMED TO THINK THIS HOSE, AND PERHAPS EARLIER VERSIONS OF THE CLIMATELINE AIR 11 HOSES THAT I¿VE USED FOR THE PAST 7 YEARS, ARE SATURATED IN UNSEEN CHEMICALS. I WOULD NOT KEEP A DECORATIVE ITEM OR SOME OTHER NON-ESSENTIAL PURCHASE IN MY HOME IF IT ARRIVED SMELLING THIS WAY, MUCH LESS A TRUSTED MEDICAL PRODUCT THAT I SLEEP IN AND BREATHE THROUGH NIGHT AFTER NIGHT. I¿M ESPECIALLY DISTURBED TO THINK NOT A SINGLE PERSON AT RESMED OR AEROCARE NOTICED OR QUESTIONED THIS STRONG AND OFFENSIVE SMELL BEFORE SHIPPING. IT WORRIES ME TO THINK THIS ODOR-FILLED PRODUCT IS PERHAPS CONSIDERED ¿NORMAL¿ AND THAT THIS OCCURS FREQUENTLY? THIS IS NOT THE OPINION OF ONE CPAP PATIENT BEING OVERLY PARTICULAR ABOUT HOW SOMETHING SMELLS. MY HUSBAND AGREED THAT THE HOSE, AND THE OTHER ITEMS WITH WHICH IT WAS PACKED, HAS AN AGGRESSIVELY OFFENSIVE ODOR, AND THAT NOTHING FROM THE BOX SHOULD BE USED. TO DOCUMENT MY EXPERIENCE, I WILL TAKE THE HOSE AND OTHER AFFECTED PRODUCTS TO MY DOCTOR¿S OFFICE TODAY FOR THEM TO BECOME INFORMED OF THIS PROBLEM AND TO VERIFY THAT THE PRODUCT CONTINUES TO HAVE A STRONG PETROLEUM ODOR. PLEASE RESPOND TO THIS EMAIL OR CALL ME AT (B)(6) TO HELP ME RESOLVE THIS UNSETTLING MATTER. (B)(6). NOTES OF MY ATTEMPTS TO NOTIFY RESMED AND AEROCARE RE PROBLEM SO THEY CAN FIGURE OUT IF OTHER HOSES ARE CONTAMINATED AND ENSURE THIS DOESN¿T HAPPEN AGAIN: MONDAY, JULY 8: DR. (B)(6) STAFF: AGREED TUBING WAS UNUSABLE AND SMELLED TERRIBLE. XEROXED MY EMAILED COMPLAINT TO RESMED AND AEROCARE; CONTACTED LOCAL AEROCARE REP (B)(4) ON MY BEHALF. TUESDAY, JULY 9: RECEIVED FORM LETTER RESPONSE FROM RESMED IN RESPONSE TO MY EMAIL TELLING ME TO CONTACT MY EQUIPMENT PROVIDER AND SWAP OUT THE AFFECTED COMPONENT. I RESPONDED TO THIS FORM LETTER JULY 10 ASKING TO SPEAK TO SOMEONE ABOUT THIS PROBLEM AND I HAVEN¿T HEARD BACK. RECEIVED CALL FROM (B)(4), LOCAL AEROCARE SALES REP WHO HANDLES DR. (B)(6) ACCOUNT TELLING ME TO ¿SWING BY AND SWAP IT OUT.¿ I CALLED HER BACK: SHE SEEMED DISINTERESTED; SAID THERE IS NOTHING SHE CAN DO; DOESN¿T HAVE A NAME OR NUMBER OF ANYONE WITHIN RESMED OR AEROCARE; SAID SUPPLIES COME FROM SEVERAL AEROCARE WAREHOUSES-DIDN¿T KNOW THIS ONE WAS FROM (B)(6). I ASKED FOR SOMEONE AT AEROCARE TO CALL TO DISCUSS THIS WITH; SHE DIDN¿T HAVE A NUMBER; I PRESSED HER TO CALL ME BACK TOMORROW AND SAID I COULD CALL HER AS WELL; SHE SAID MAYBE SHE COULD GIVE ME RESMED¿S MAIN NUMBER BUT DIDN¿T SOUND AS THOUGH SHE WOULD REALLY CALL ME BACK. I WENT TO TULSA AEROCARE OFFICE AROUND 3:30 PM. AEROCARE EMPLOYEE (B)(4) WAS DISINTERESTED; SAID SHE¿D NEVER HEARD OF A PRODUCT SMELLING BAD; SOLD ME A NEW HOSE ((B)(6)) AS INSURANCE WILL ONLY COVER A SWAP; SAID TULSA AEROCARE MANAGER WAS ¿CONTACTING SNAP¿ ABOUT THIS MATTER WHEN I EXPRESSED DISSATISFACTION ABOUT AEROCARE¿S LACK OF INTEREST IN MY PROBLEM. MANAGER, (B)(4), NOT AVAILABLE TO SEE ME. I ASKED WHEN WOULD BE A GOOD TIME TO CALL AND ACTUALLY REACH (B)(4) AND WAS TOLD 2:30. I SAID I¿D CALL BACK THE FOLLOWING DAY AROUND 2:30 TO DISCUSS. WEDNESDAY, JULY 10: CALLED AEROCARE TULSA¿S MAIN OFFICE NUMBER AROUND 2:30 PM. HELD FOR 7 MINUTES AND WAS DISCONNECTED. CALLED AGAIN AND CHOSE OPTION 2 FROM THE RECORDED MESSAGE; WAS CONNECTED WITH AN OFFSITE BILLING OFFICE. REP VERY HELPFUL, TRIED TO CONNECT ME TWICE, SAID THE TULSA OFFICE ¿WAS UNABLE TO TAKE ANY CALLS AS IT WAS HAVING TECHNICAL DIFFICULTIES.¿ HE GAVE ME THE SAME NUMBER I HAD ORIGINALLY CALLED (B)(6) AND SAID TO TRY AGAIN ANOTHER TIME. THURSDAY, JULY 10: CALLED (B)(6) OFFICE OF FDA (B)(4) AS INSTRUCTED FOR (B)(6) COMPLAINTS. LEFT MESSAGE AROUND 11:30 A.M.; (B)(4) QUICKLY RESPONDED AND WE¿VE EXCHANGED PHONE MESSAGES ALMOST DAILY AS WE ATTEMPT TO REACH EACH OTHER. WEDNESDAY, JULY 17: SENDING (B)(4) MY EMAIL TO RESMED/AEROCARE AND THIS TIME LINE SO SHE CAN ADDRESS MY CONCERNS WHEN SHE RETURNS TO THE OFFICE 7/23. INFO (B)(4) REQUESTED (ALL FROM PRODUCT LABELS): PRODUCT MANUFACTURED BY RESMED: CLIMATELINE AIR 11 AMER, REF 39102 MADE IN SINGAPORE, RESMED 1 ELIZABETH MACARTHUR DRIVE, BELLA VISTA NSW 2163 AUS. LOT (10) 1739103. PRODUCT DISTRIBUTED BY AEROCARE AND MAILED FROM: AEROCARE CPAP SUPPLY CENTER, 1055 SOUTHTOWN DRIVE, WATERLOO, IA 60702. REFER TO ADD'L DOCUMENTS IN I2K.