INOVO

Description of Event or Problem

INOVO INC. WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONSERVER BY A PROVIDER WHO STATED THAT "A PATIENT HAD FITTED THE CONSERVER ONTO A CH MEDICAL OXYGEN CYLINDER BUT DID NOT TURN IT ON. APPROXIMATELY 24 HOURS LATER, THE PATIENT NEEDED TO VISIT THE GP AND WHEN OUTSIDE THE GP'S CLINIC THEY TURNED IT ON. AT THAT POINT THE PATIENT HEARD A HISSING NOISE AND THEN A BANG." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. INOVO EVALUATED THE PRODUCT, WHICH REVEALED 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 ADDRESSED BY THE DEVICE'S INSTRUCTIONS FOR USE.