Description of Event or Problem · 1
WHAT WE FOUND WAS THAT WHERE THE OXYGEN TUBING WAS CONNECTED TO THE BACK OF THE BAG VALVE MASK, AN ACUTE BEND WAS MADE AND CONCEALED BY THE OXYGEN RESERVOIR. APPARENTLY THIS BEND LED TO A KINK AND OCCLUSION OF THE OXYGEN LINE, HENCE NO OXYGEN FLOW TO THE MASK AT 15L/MIN. A SECOND SYSTEM WAS INSPECTED AND FOUND THE SAME THING. I¿M NOT SURE IF IT¿S DUE TO JUST THE KINKING, OR WHETHER THE TUBING IS SOFT ENOUGH TO PARTIALLY FUSE IN POSITION. I ALSO DON¿T KNOW IF THERE ARE TEMPERATURE SPECIFICATIONS FOR THIS DEVICE THAT MAY HAVE BEEN EXCEEDED IN AMBULANCE STORAGE. EITHER WAY, IT LED TO REAL LIFE INABILITY TO DELIVER OXYGEN ABOVE ROOM AIR LEVELS FOR A PT WHO NEEDED IMMEDIATE INTUBATION ON ARRIVAL TO THE EMERGENCY DEPARTMENT. I HAVE LEARNED THAT THE AMBULANCES HAVE NO AIR CONDITIONING, SO THE TEMPERATURE CAN GET QUITE HIGH, WHICH MAY HAVE HAD AN IMPACT ON THE PRODUCT. INVESTIGATION RESULTS: COMPLAINT REPORT ASSOCIATED NSN (B)(4) WITH CAREFUSION PART NUMBER 2K8004, BUT THEY ARE NOT EQUIVALENT DEVICES. THERE ARE TWO SOURCES FOR THIS NSN; PURITAN BENNETT P/N 133255 AND VITAL SIGNS P/N 7000A. THE CAREFUSION DEVICE WAS PROCURED THROUGH DAPA FROM CAREFUSION THROUGH CARDINAL NOT BY NSN. REPORTING ACTIVITY IS IN THE PROCESS OF SWITCHING TO AMBU DUE TO MMSEO STANDARDIZATION INITIATIVE. THE DEFECTIVE ITEM IS NOT AVAILABLE FOR INSPECTION BECAUSE THEY HAVE BEEN DISCARDED.