MEDLINE ADULT RESUSCITATION BAG, TUBING RESERVOIR, MANOMETER, PRE-ATTACHED PEEP

Description of Event or Problem

PER REPORT, "PATIENT SELF EXTUBATED. UPON MY ARRIVAL TO THE ROOM. MD AND RN WERE MANUALLY VENTILATING THE PATIENT WITH AMBUT BAG BUT THE O2 TUBING AND RESERVOIR TO THE AMBU BAG WAS DISCONNECTED. BOTH WERE RECONNECTED AND PAITENT WAS REINTUBATED. I AM AWARE THIS HAS BEEN AN ISSUE WITH THIS AMBU BAG. I INFORMED THE MD AND RN ABOUT THIS ONGOING SAFETY ISSUE. THE DISCONNECTION OF THE O2 TUBING AND RESERVOIR TUBING HAVE BEEN OF CONCERN FOR MANY WEEKS AT THE LEGACY SYSTEM. PRODUCT MANAGEMENT TEAM IS AWARE OF THIS."

Additional Manufacturer Narrative

PER REPORT, "PATIENT SELF EXTUBATED. UPON MY ARRIVAL TO THE ROOM. MD AND RN WERE MANUALLY VENTILATING THE PATIENT WITH AMBUT BAG BUT THE O2 TUBING AND RESERVOIR TO THE AMBU BAG WAS DISCONNECTED. BOTH WERE RECONNECTED AND PAITENT WAS REINTUBATED. I AM AWARE THIS HAS BEEN AN ISSUE WITH THIS AMBU BAG. I INFORMED THE MD AND RN ABOUT THIS ONGOING SAFETY ISSUE. THE DISCONNECTION OF THE O2 TUBING AND RESERVOIR TUBING HAVE BEEN OF CONCERN FOR MANY WEEKS AT THE LEGACY SYSTEM. PRODUCT MANAGEMENT TEAM IS AWARE OF THIS." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.