BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WESTMED LLC

    MDR report key: 16824695 · Received April 27, 2023

    Report

    Report Number
    2028807-2023-00013
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    March 14, 2023
    Report Date
    April 27, 2023
    Manufacturer
    WESTMED LLC
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS MANUAL RESUSCITATION FAILED TO PROVIDE ADEQUATE VENTILATION. 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.

    Additional Manufacturer Narrative · 0

    REPORTABLE AS MANUAL RESUSCITATION FAILED TO PROVIDE ADEQUATE VENTILATION.

    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 (B)(4)) 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.

    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 (B)(4)) 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
    1613188 WESTMED LLC ADULT BAGEASY, RESUSCITATOR, W/PEEP AND MASK BTM WESTMED LLC 562048 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other