BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY RESUSCITATOR AMBU BAG

    MDR report key: 16610626 · Received March 23, 2023

    Report

    Report Number
    MW5115952
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    March 14, 2023
    Report Date
    March 21, 2023
    Manufacturer
    WESTMED, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTED FAILURE OF MANUAL SELF-INFLATING RESUSCITATION BAG DEVICE ("AMBU BAG") DURING LARYNGOSCOPY. ANESTHESIA NOTED HIGH PRESSURE TO VENTILATE A PATIENT UNDER GENERAL ANESTHESIA, AFTER INTUBATION. ANESTHESIA SWITCHED TO MANUAL RESUSCITATION WITH CONTINUED DECREASE IN OXYGEN LEVELS. SUBSEQUENT RESPIRATORY AND CARDIAC ARREST. ATTENDING SURGEON PERFORMED EMERGENT TRACHEOSTOMY INCISION, CONFIRMED ENDOTRACHEAL TUBE IN PLACE, AND DID NOT COMPLETE INSERTION OF TRACHEOSTOMY. DIFFERENT BRAND OF RESUSCITATION BAG OBTAINED AND OXYGEN SATURATION RECOVERED. AFTER RETURN OF SPONTANEOUS CIRCULATION, SURGERY ABORTED AND PATIENT ADMITTED TO INTENSIVE CARE UNIT. UPON REVIEW, PREVIOUS EPISODE OF FAILURE OF SELF-INFLATING RESUSCITATION BAG DEVICE (WEST MED BAG EASY RESUSCITATOR REF 562048) IN (B)(6) 2022 AFTER EVENT IN EMERGENCY DEPARTMENT WITH SEVERAL BAGS USED DURING CODE EVENT. FAILURE APPEARS TO BE WHEN BAG IS PULLED FROM THE MOUTHPIECE DURING PREPARATION, CAUSING A LEAK IN THE FLANGE BETWEEN THE HARD PLASTIC MOUTHPIECE AND SOFT BAG PORTION. THIS MAY BE A DISCONNECT OR TEAR IN THE RESERVOIR BAG OR SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522109 EASY RESUSCITATOR AMBU BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM WESTMED, INC. 562048

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| O| H