Description of Event or Problem · 1
I AM WRITING TO REPORT A SERIOUS FAILURE OF AN OXLIFE TRAVEL OXYGEN CONCENTRATOR (B)(6) 2016 RENTED FROM (B)(6)). THE FAILURE CAUSED MY MOTHER-IN-LAW, (B)(6), TO SUFFER WITHOUT OXYGEN AT THE END OF HER FLIGHT FROM (B)(6) AND THEN FORCED HER TO TAKE AN AIR AMBULANCE FOR HER LAST FLIGHT RETURNING HOME TO (B)(6). MEDICAL PROFESSIONALS AT THE (B)(6) AIRPORT DETERMINED THE AIR AMBULANCE WAS MEDICALLY NECESSARY BECAUSE THE AIRLINE WAS UNABLE TO ALLOW HER TO FLY DUE TO MEDICALLY NECESSITATING OXYGEN PRIOR TO THE TRIP. THE ONLY WAY FOR HER TO RETURN HOME AND COST OUR FAMILY MORE THAN (B)(6) THAT HAS NOT BEEN REIMBURSED BY HEALTH INSURANCE. SHE PASSED AWAY (B)(6) 2016 ENDING HER BATTLE WITH CANCER. THE DEVICE FAILED TO CHARGE THE BATTERIES WHILE PROVIDING HER OXYGEN AND THE MALFUNCTION WAS OBSERVED BY (B)(6) AIRPORT EMT'S. (B)(6) DAUGHTER ((B)(6), A FAMILY MEDICINE PHYSICIAN), HER BOYFRIEND ((B)(6), A MECHANICAL AND ELECTRICAL ENGINEER), AND (B)(6) MOTHER ((B)(6), A HOSPICE VOLUNTEER) WHILE ALL WERE ON THE PHONE WITH THE RENTAL COMPANY REPRESENTATIVE WHO CONFIRMED THE DEVICE WAS NOT FUNCTIONING PROPERLY DUE TO BEING CONNECTED TO WALL OUTLET FOR 2 HOURS ON THE PHONE WITH THEM AND NOT EVEN GAINING A SINGLE BAR OF BATTERY POWER ON THE DISPLAY. THE TECHNICAL SUPPORT REPRESENTATIVE SIMPLY SUGGESTED THEY LABEL THE MALFUNCTIONING BATTERIES AND SEND IT BACK TO THEM, WHICH DID NOTHING TO PROVIDE HER WITH THE NECESSARY OXYGEN TO GET HER HOME. WHEN THEY MENTIONED THIS, THEY POINTED OUT (B)(6) MUST HAVE OXYGEN, SO SIMPLY TAKING HER OFF TO SEND ALL THE BATTERIES (NONE WERE CHARGING WHEN MACHINE ALSO BEING USED AT THE SAME TIME) WAS NOT AN ACCEPTABLE OPTION. THE SERVICE REP. THEN SUGGESTED LEAVING HER ATTACHED TO THE WALL OUTLET CONTINUOUSLY, WHICH ALSO MEANT THAT IF SHE HAD TO USE THE BATHROOM THAT WAS FORCED TO CHOOSE BETWEEN USING THE BATHROOM ON HERSELF IN ORDER TO GET OXYGEN OR GO WITHOUT OXYGEN AND BE HYPOXIC WHEN ALREADY TERMINALLY ILL IF DID NOT WANT TO USE THE BATHROOM ALL OVER HERSELF. THE AMBULANCE CONFIRMED HER OXYGEN LEVEL WAS LOW ON THE 3L NASAL CANNULA OXYGEN FROM THE MACHINE BUT WHEN CONNECTED TO THEIR OXYGEN AT THE SAME FLOW RATE HAD INSTANT INCREASE IN OXYGEN LEVEL, WHICH FURTHER CONFIRMS THE DEVICE WAS NOT WORKING PROPERLY. MY WIFE BELIEVES SHE INFORMED (B)(6) OF THIS VIA EMAIL AND OVER THE PHONE. (THIS WAS INITIALLY USING HER OWN SALINE TUBING SO WAS NOT SIMPLY THAT THERE WAS A PROBLEM WITH THE TUBING.) OUR CONCERNS WITH THE DEVICE MALFUNCTION INCLUDE: FAILURE TO CHANGE THE BATTERIES, FAILURE TO DELIVER THE PROGRAMMED OXYGEN CONCENTRATION AND; THE DEVICE PASSED THE RENTAL COMPANIES ANALYSIS STATING THE DEVICE AND BATTERIES ALL WORKED PROPERLY BUT DID NOT HAVE A REPORT ON THE ANALYSIS CONDUCTED TO SHARE WITH US. I ((B)(6)) SPOKE WITH THE SERVICE MANAGER, (B)(6), HE INDICATED THAT THEY DID NOT HAVE A REPORT AND SHARED POSSIBLE THEORIES INCLUDING: IT MAY BE POSSIBLE TO INSERT THE BATTERIES AND THE DISPLAY REGISTER THEM AS INSERTED AND CHARGING BUT NOT ACTUALLY CONNECTED TO CHARGE THEM. THE DEVICE MAY NOT BE ABLE TO CHARGE THE BATTERIES WHILE DELIVERING HIGHER OXYGEN LPM SETTINGS. THE (B)(6) REPEATED THE ANALYSIS FOUND THE DEVICE AND BATTERIES WORKING PROPERLY AND CONSIDERED THE MATTER CLOSED. WE ARE CONCERNED THAT THE RENTAL COMPANY MAY HAVE FAILED TO PROPERLY ANALYZE AND TRACK THE DEVICE AND BATTERIES PUTTING OTHER CUSTOMERS AT RISK AND DID NOT NOTIFY THE MANUFACTURER. ALSO THE DEVICE MAY HAVE DESIGN AND RELIABILITY ISSUES/COMPLEXITIES THAT PUT OXYGEN DEPENDENT PATIENTS AT RISK. LAST, BECAUSE PATIENT'S MAY BE DEALING WITH COMPLEX END OF HEALTH ISSUES, THE ROLE OF DEVICE MALFUNCTION AND LACK OF OXYGEN CONTRIBUTING TO THEIR DEATH MAY BE DIFFICULT TO ACCOUNT FOR IN EACH CASE. (B)(6) WENT ON THE TRIP WITH CONSENT OF PALLIATIVE CARE PROVIDER AS END OF LIFE DREAM. SHE WAS ACCOMPANIED BY HER FAMILY INCLUDING HER DAUGHTER (FAMILY MEDICINE PHYSICIAN), MOTHER (HOSPICE VOLUNTEER), SON IN-LAW (BIOMEDICAL ENGINEER), AND BOYFRIEND (MECHANICAL AND ELECTRICAL ENGINEER) AND NEVER LEFT ALONE FOR ANY PART OF THE TRIP. ON THE CRUISE SHIP SHE HAD TO USE A DIFFERENT OXYGEN CONCENTRATOR REQUIRED BY THE CRUISE LINE WITH NO PROBLEMS. RENTAL: (B)(6).