BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAGEASY RESUSCITATOR

    MDR report key: 16662745 · Received April 3, 2023

    Report

    Report Number
    16662745
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 24, 2023
    Report Date
    March 30, 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 EMERGENCY ROOM 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535573 BAGEASY RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM WESTMED, INC. 562048 071122U10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H