IMPULSE ELITE
Received Sep 12, 2013 · Event occurred Aug 7, 2013
Report 1319044-2013-00009 · MDR key 3390927
Device
Generic name
Oxygen Conserving Device
Manufacturer
Airsep Corp.Model number
OC006-1Catalog number
OC006-1
Product problems
- Thermal Decomposition of Device
- Fire
- Melted
- Smoking
Patient
Not reported
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
WAITING FOR RETURN OF DEVICE TO EVALUATE. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE EVAL.
Description of Event or Problem
PT'S WIFE CHANGED AN OXYGEN CYLINDER CONNECTED TO THE IMPULSE ELITE OXYGEN CONSERVING DEVICE, WITH A NEW FULL TANK. WHEN THE WIFE TURNED THE TANK ON, FLAMES SHOT UP FROM THE CYLINDER. THIS CAUSED IGNITION/MELTING OF THE IMPULSE ELITE AND OXYGEN BAG. IT IS UNK AS TO WHAT CAUSED THE FIRE. THE WIFE SUFFERED 2ND AND 3RD DEGREE BURNS TO HER HAND. PROPERTY DAMAGE TO THE DINING ROOM TABLE, HARDWOOD FLOOR, AND SMOKE SOOT IN HOUSE. WIFE MANAGED TO PUT OUT FIRE.