InjuryJRO
OXYGEN-AIR BLENDER
Received Jul 31, 1997 · Event occurred Jun 30, 1997
Report 1828100-1997-00013 · MDR key 109568
Device
Generic name
Oxygen-air Blender
Manufacturer
3m Health Care Sarns And Cdi ProductsModel number
78-8066-9202-2Catalog number
NA
Lot number
NA
Patient
58 YR
Narrative
Description of Event or Problem
DURING THE BYPASS PROCEDURE, THE SURGICAL TEAM NOTICED A GRADUAL DROP IN THE PATIENT'S VENOUS OXYGEN SATURATION. USING THE OXYGEN-AIR BLENDER, THEY ATTEMPTED TO RAISE THE SATURATION LEVEL, BUT THEY COULD NOT RAISE THE LEVEL ABOVE 45%. IT HAS SINCE BEEN CONFIRMED THAT THE OXYGEN-AIR BLENDER HAD FAILED TO DELIVER THE SPECIFIED CONCENTRATION OF OXYGEN TO THE PATIENT. THERE HAS BEEN NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.