AMBU SPUR II ADULT BAG RES

Additional Manufacturer Narrative

NO SAMPLE WAS RETURNED FOR INVESTIGATION, NOR WAS A LOT NUMBER PROVIDED. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED FAILURE AS NO SAMPLE WAS AVAILABLE FOR INVESTIGATION, FURTHER THERE IS LIMITED INFORMATION ON THE REPORTED FAILURE TO ASSIST IN THE INVESTIGATION. HENCE, A ROOT CAUSE CANNOT BE IDENTIFIED. BASED ON DESCRIPTION OF EVENT, WE INFER THAT THE INCIDENT MAY BE DUE TO INSUFFICIENT VENTILATION THAT CAUSED THE PATIENT UNABLE TO MAINTAIN GOOD SATURATION. THE POSSIBLE CAUSE OF INSUFFICIENT VENTILATION MAY BE DUE TO PATIENT VALVE DISC OR INLET VALVE DISC MISSING OR MALFUNCTION. HOWEVER, AS NO SAMPLE HAS BEEN RETURNED AND DUE TO LIMITED INFORMATION, THE REPORTED FAILURE AND ROOT CAUSE CANNOT BE DETERMINED. AMBU WILL KEEP MONITORING IT AND TAKE ACTIONS IF NECESSARY.

Description of Event or Problem

PER MAUDE REPORT: PATIENT WAS IN DIALYSIS RECEIVING HER FIRST INTERMITTENT HEMODIALYSIS RUN AND AN HOUR INTO HER RUN, WENT UNRESPONSIVE. PATIENT STARTED DESATURATING, CLOSE FACE MASK APPLIED AT "FLUSH" RATE. PATIENT STILL UNABLE TO MAINTAIN GOOD SATURATIONS. EMERGENCY AMBU BAG THAT WAS IN ROOM WAS ACCESSED AND HOOKED UP TO OXYGEN, APPLIED OVER MOUTH, HOWEVER THE PATIENT CONTINUED TO DESATURATE DESPITE ATTEMPTING MANUAL BREATHS AND BEING HOOKED UP TO THE OXYGEN THROUGH AMBU BAG TUBING. PATIENT PLACED BACK ONTO CLOSED FACE MASK AND RRT ARRIVED AT BEDSIDE. AMBU BAG WAS HOOKED UP TO ANOTHER OXYGEN TREE IN ANOTHER ROOM TO ASSESS QUALITY AND FUNCTION AND WAS FOUND TO BE MALFUNCTIONED, NOT ALLOWING ANY AIR THROUGH THE MASK.