Description of Event or Problem · 1
DEVILBISS RECEIVED A REPORT FROM A CUSTOMER REGARDING A FIRE THAT RESULTED IN THE DEATH OF A PATIENT. THERE WAS REPORTEDLY A DEVILBISS OXYGEN CONCENTRATOR IN THE ROOM WHERE THE FIRE OCCURRED. HOWEVER, THE CUSTOMER LATER REPORTED THAT THE PATIENT'S RELATIVE INFORMED HER THAT THE FIRE MARSHAL HAD INVESTIGATED THE SCENE OF THE FIRE AND "IT WAS RULED ACCIDENTAL DUE TO PATIENT SMOKING," AND THAT THE CASE HAD BEEN CLOSED. TO VERIFY, DEVILBISS RECEIVED THE OXYGEN CONCENTRATOR FOR EVALUATION, AND DETERMINED THAT IT COULD NOT HAVE BEEN THE CAUSE OF THE FIRE. SEE IN SUM, BASED ON THE THERMAL DAMAGE PROFILE AND THE LACK OF DAMAGE TO ANY OF THE INTERNAL OXYGEN PATH COMPONENTS, IT WAS CONCLUDED THAT THE THERMAL EVENT DID NOT PROPAGATE THROUGH THE UNIT BY WAY OF THE OXYGEN GAS PATH. SINCE THERE WAS EXTENSIVE DAMAGE AT THE OUTLET PORT AREA OF THE DEVICE, IT IS BELIEVED THAT THE FIRE ORIGINATED FROM AN EXTERNAL SOURCE AND TRAVELED TO THE OUTLET PORT OF THE UNIT VIA THE CANNULA. THE METAL OUTLET FITTING, WHICH WAS MISSING FROM THE UUT, IS DESIGNED TO PREVENT FIRE INGRESS TO THE DEVICE, SINCE IT DOES NOT PROVIDE THE NECESSARY FUEL FOR THE FIRE TO CONTINUE UPSTREAM OF THE OXYGEN GAS PATH. IF THE THERMAL EVENT HAD INITIATED INTERNALLY IN THE DEVICE, AND PREVENTED PROPER OPERATION OF ANY SUBSYSTEM OF THE PRODUCT TO PRODUCE OXYGEN, THEN THE DAMAGE AT THE OUTLET FITTING WOULD NOT HAVE BEEN AS EXTENSIVE AS WHAT WAS OBSERVED.