WESTMED

Additional Manufacturer Narrative

THE RESERVOIR BAG NOT STAYING ATTACHED AND LEAKING WOULD DELAY THE VENTILATION OF THE PATIENT. COMPLAINT WAS CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED FOR IF THE COMPLAINT WAS DUE TO ASSEMBLY ERROR OR HANDLING ERROR WHEN DEVICE WAS BEING PREPPED FOR USE. INVENTORY COULD NOT REPEAT THE REPORTED DEFECT; HOWEVER, AN ADDITIONAL INSPECTION WAS CREATED TO ENSURE PRODUCT MAINTAINS PULL FORCE CONSISTENCY.

Description of Event or Problem

BAGS ARE LEAKING.  SEVERAL INCIDENTS ASSOCIATED WITH SAME PRODUCT WHICH COULD OF LED TO PATIENT DEATH. THE BAG IS DETACHED AT THE END OF THE BULB CAUSING THE LEAK IN MANY OF THESE AMBU BAGS. ALSO, THE VALVE TENDS TO GET STUCK IN ONE EVENT. THIS IS VERY SERIOUS AND WHEN EMERGENCIES OCCUR AND PATIENTS NEED TO BE RESUSCITATED, THERE IS NO TIME TO GET ANOTHER BAG IF DEFECTIVE PRODUCTS ARE FURTHER IDENTIFIED AND PATIENT MAY DIE. A FACILITY REPORTED THERE WAS A CODE IN THE ER IN WHICH 4 AMBU BAGS (ALSO CALLED BAG VALVE MASK) WERE USED ON ONE PATIENT AND ALL 4 WERE FOUND TO HAVE A LEAK OR FAIL TO SEAL AROUND THE PATIENT'S MOUTH. EMERGENCY TRACHEOSTOMY HAD TO BE PERFORMED. A FACILITY REPORTED, A PATIENT HAD A BRONCHOSPASM, AND WHEN THE AMBU BAG WAS DEPLOYED, THERE WERE AIR LEAKS AND UNABLE TO USE. ANOTHER FACILITY HAD PATIENT CRASH AND UPON DEPLOYING AMBUBAG, IT HAD AIRLEAKS AND THE VALVE WAS STUCK AS WELL.

Description of Event or Problem

BAGS ARE LEAKING.  SEVERAL INCIDENTS ASSOCIATED WITH SAME PRODUCT WHICH COULD OF LED TO PATIENT DEATH. THE BAG IS DETACHED AT THE END OF THE BULB CAUSING THE LEAK IN MANY OF THESE AMBU BAGS. ALSO, THE VALVE TENDS TO GET STUCK IN ONE EVENT. THIS IS VERY SERIOUS AND WHEN EMERGENCIES OCCUR AND PATIENTS NEED TO BE RESUSCITATED, THERE IS NO TIME TO GET ANOTHER BAG IF DEFECTIVE PRODUCTS ARE FURTHER IDENTIFIED AND PATIENT MAY DIE. A FACILITY REPORTED THERE WAS A CODE IN THE ER IN WHICH 4 AMBU BAGS (ALSO CALLED BAG VALVE MASK) WERE USED ON ONE PATIENT AND ALL 4 WERE FOUND TO HAVE A LEAK OR FAIL TO SEAL AROUND THE PATIENT'S MOUTH. EMERGENCY TRACHEOSTOMY HAD TO BE PERFORMED. A FACILITY REPORTED, A PATIENT HAD A BRONCHOSPASM, AND WHEN THE AMBU BAG WAS DEPLOYED, THERE WERE AIR LEAKS AND UNABLE TO USE. ANOTHER FACILITY HAD PATIENT CRASH AND UPON DEPLOYING AMBUBAG, IT HAD AIRLEAKS AND THE VALVE WAS STUCK AS WELL.

Additional Manufacturer Narrative

THE RESERVOIR BAG NOT STAYING ATTACHED AND LEAKING WOULD DELAY THE VENTILATION OF THE PATIENT.