Description of Event or Problem · 0
DEVICE: INOGEN OXYGEN GENERATOR MODEL: GS-100 SERIAL NUMBER (B)(6) PATIENT: (B)(6) DOB (B)(6). MY FATHER, A (B)(6) YEAR OLD MALE WITH CONGESTIVE HEART FAILURE, ONE FUNCTIONAL LUNG AND HEARING LOSS USED THE ABOVE INOGEN OXYGENATOR TO MAINTAIN HIS BLOOD OXYGEN LEVEL. HE EMPLOYED THE INOGEN DEVICE AT NIGHT WHILE HE SLEPT AND USED ANOTHER PORTABLE UNIT WHEN ACTIVE AROUND HIS ASSISTED-LIVING FACILITY. THE DEVICE USED A SEPARATE NEMA 5-15P TO C13 POWER CORD; ONE END PLUGGED INTO THE 110V WALL OUTLET AND THE OTHER END PLUGGED INTO THE DEVICE. UNKNOWN TO ME, THE PLUG WOULD NOT FIT TIGHTLY INTO THE UNIT; IT WOULD SLIP OUT WHENEVER IT WAS TOUCHED, NO MATTER HOW SECURELY HE WOULD TRY TO INSERT IT. IN FACT, ON THE MORNING OF THE INCIDENT I DISCOVERED THAT MY FATHER HAD TRIED TO SECURE THE PLUG WITH GREEN ELECTRICAL TAPE TO KEEP IT IN (I HAVE PHOTOS). ADDITIONALLY, THE OXYGEN GENERATOR HAD NO POWER FAILURE ALARM. ON THE NIGHT OF JUNE 9, MY FATHER WENT TO BED AS USUAL WITH THE MACHINE TURNED ON, THE WATER BUBBLING AND WEARING HIS CANNULA. HOWEVER, AT ABOUT 1:00AM HE AWOKE AND SAT UP TO ADJUST HIS BLANKETS, THEN RETURNED TO SLEEP. APPARENTLY, HIS FOOT TOUCHED THE POWER CORD AND IT SEPARATED FROM THE MACHINE. BECAUSE HE WAS DEAF WITHOUT HIS HEARING AIDS AT NIGHT, HE DID NOT KNOW THAT THE MACHINE WAS WITHOUT POWER AND NOT OPERATING. AT ABOUT 5:00AM, MY FATHER AWOKE FEELING DIZZY, DISORIENTED, CONFUSED AND WEAK. HE PULLED HIS EMERGENCY CORD TO CALL THE ON-CALL NURSE AT THE ASSISTED LIVING FACILITY. THE NURSE MEASURED HIS SO2 OXYGEN SATURATION AND HE WAS AT 40%. IT WAS THEN DISCOVERED THAT THE MACHINE WAS OFF BECAUSE THE CORD HAD COME LOOSE, AND HE HAD BEEN WITHOUT OXYGEN FOR MORE THAN 4.5 HOURS. IT TOOK MY FATHER TWO DAYS TO FEEL SOMEWHAT NORMAL; TO GET HIS BEARING AND FOR HIS SPEECH TO STOP SLURRING DUE TO THE EXTENDED PERIOD OF OXYGEN DEPRIVATION. I CONTACTED THE COMPANY TO ALERT THEM ABOUT THE PROBLEM, AND THEY OVERNIGHT-SHIPPED A NEW POWER CORD WHICH WOULD FIT A BIT MORE SNUGLY, BUT COULD STILL BE DISLODGED EASILY. I AM A PROFESSOR AND ASSOCIATE DEAN OF RESEARCH AT (B)(6). I HAVE MANY YEARS OF EXPERIENCE OF RESEARCH AND CLINICAL TRIALS WITH MEDICAL DEVICES, AND I FIND IT PREPOSTEROUS THAT A MEDICAL DEVICE THIS IMPORTANT WOULD NOT USE A BETTER POWER INTERFACE THAN A NEMA 5-15P TO C13 POWER CORD, WHICH IS MEANT MORE FOR COMPUTERS THAN FOR LIFE-SUSTAINING MEDICAL DEVICES. THERE SHOULD BE EITHER A BAYONET MOUNT OR OTHER METHOD OF SECURING THE POWER CONNECTOR. MY FATHER PASSED AWAY ON JUNE 25. I DO NOT BELIEVE THAT HIS DEATH WAS RELATED TO THE INCIDENT WITH THE OXYGENATOR, BUT I FEEL STRONGLY THAT THE INOGEN MODEL GS-100 SYSTEM AND ANY SIMILAR ONES WITH THIS DESIGN FLAW SHOULD BE RECALLED AND REMEDIATED AS SOON AS POSSIBLE TO PREVENT INJURY OR DEATH TO A USER. PLEASE FOLLOW-UP TO CONFIRM THAT THIS REPORT HAS BEEN FILED, AND TO LET ME KNOW WHAT OTHER DOCUMENTATION YOU REQUIRE. I THANK YOU FOR YOUR ATTENTION AND ASSISTANCE. (B)(6).