INOVO

Description of Event or Problem

INOVO INC. WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONSERVER BY A PROVIDER WHO STATED THAT "AN END USER ATTACHED A FULL CYLINDER TO THE OXYGEN CONSERVER AND WHEN HE OPENED THE CYLINDER A LARGE FLASH WAS SEEN." THE END USER IMMEDIATELY CLOSED THE CYLINDER VALVE. IT WAS REPORTED THAT A LARGE AMOUNT OF SOOT WAS SEEN AROUND THE CYLINDER VALVE AND OXYGEN CONSERVER. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. INOVO EVALUATED THE PRODUCT, WHICH SUGGESTED THAT THE IGNITION MECHANISM WAS FLOW FRICTION, WHICH CAN OCCUR IF THE SEAL WASHER WEARS OVER TIME, OR IF THE DEVICE IS NOT CONNECTED TO THE COMPRESSED OXYGEN CYLINDER TIGHTLY ENOUGH, BOTH OF WHICH ARE SPECIFICALLY ADDRESSED BY THE DEVICE'S INSTRUCTIONS FOR USE.