BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAGEASY

    MDR report key: 16706707 · Received April 10, 2023

    Report

    Report Number
    16706707
    Event Type
    Death
    Date Received
    April 10, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 7, 2023
    Manufacturer
    WESTMED, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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. PRODUCT INFORMATION: MANUFACTURER PRODUCT NUMBER: 562048; MANUFACTURED BY: WESTMED. WE HAVE RECEIVED NUMEROUS REPORTS ABOUT SAME WESTBAG AMBUBAGS FAILING DUE TO A LEAK. SITES ARE REPORTING WESTMED AMBUBAG FAILING PUTTING PATIENTS IN SERIOUS RISK OF DEATH. HERE IS AN EXAMPLE OF ONE REPORT: A PATIENT ALMOST DIED. AN ENDOTRACHEAL TUBE WAS REPLACED WITH A NEW ONE, BUT THE PATIENT'S CONDITION WORSENED. DECISION WAS MADE BY THE ENT SURGEON TO PERFORM AN EMERGENCY TRACHEOSTOMY. IT WAS NOTED THAT THE ET TUBE WAS CORRECTLY PLACED, AND THE INCISION WAS CLOSED. A CRNA NOTED THAT THE AMBU-BAG WAS LEAKING, WHICH LED TO THE UNPLANNED TRACHEOSTOMY. THE PRODUCT IS AVAILABLE FOR EVALUATION. REQUEST FDA TAKE ACTION TO ENSURE MANUFACTURER TAKES ACTIONS TO IMPROVE DESIGN AND QUALITY OF PRODUCTS. THESE DEVICES ARE INTENDED TO SAVE LIVES AND NOT JEOPARDIZE AND RISK PATIENTS HEALTH AND SAFETY IN CRITICAL CIRCUMSTANCES. THE VARIOUS REPORTS WE HAVE MENTION AMBU BAGS LEAKING. THE FAILURE OF THE AMBU-BAG, WHICH HAD AN AIR LEAK, LED TO MORE PROLONGED HYPOXIA AND THE DECISION TO PERFORM AN EMERGENCY TRACHEOSTOMY. PATIENT'S CONDITION HAD DETERIORATED, AND CHEST COMPRESSIONS AND CARDIAC CODE MEDICATIONS WERE INITIATED.

    Description of Event or Problem · 0

    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. PRODUCT INFORMATION: MANUFACTURER PRODUCT NUMBER: 562048 MANUFACTURED BY: WESTMED WE HAVE RECEIVED NUMEROUS REPORTS ABOUT SAME WESTBAG AMBUBAGS FAILING DUE TO A LEAK. SITES ARE REPORTING WESTMED AMBUBAG FAILING PUTTING PATIENTS IN SERIOUS RISK OF DEATH. HERE IS AN EXAMPLE OF ONE REPORT: A PATIENT ALMOST DIED. AN ENDOTRACHEAL TUBE WAS REPLACED WITH A NEW ONE, BUT THE PATIENT'S CONDITION WORSENED. DECISION WAS MADE BY THE ENT SURGEON TO PERFORM AN EMERGENCY TRACHEOSTOMY. IT WAS NOTED THAT THE ET TUBE WAS CORRECTLY PLACED, AND THE INCISION WAS CLOSED. A CRNA NOTED THAT THE AMBU-BAG WAS LEAKING, WHICH LED TO THE UNPLANNED TRACHEOSTOMY. THE PRODUCT IS AVAILABLE FOR EVALUATION. REQUEST FDA TAKE ACTION TO ENSURE MANUFACTURER TAKES ACTIONS TO IMPROVE DESIGN AND QUALITY OF PRODUCTS. THESE DEVICES ARE INTENDED TO SAVE LIVES AND NOT JEOPARDIZE AND RISK PATIENTS HEALTH AND SAFETY IN CRITICAL CIRCUMSTANCES. THE VARIOUS REPORTS WE HAVE MENTION AMBU BAGS LEAKING. THE FAILURE OF THE AMBU-BAG, WHICH HAD AN AIR LEAK, LED TO MORE PROLONGED HYPOXIA AND THE DECISION TO PERFORM AN EMERGENCY TRACHEOSTOMY. PATIENT'S CONDITION HAD DETERIORATED, AND CHEST COMPRESSIONS AND CARDIAC CODE MEDICATIONS WERE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754923 BAGEASY VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM WESTMED, INC. 562048 071122U10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| D| R