BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU AURAGAIN LARYNGEAL MASK AIRWAY

    MDR report key: 6673029 · Received June 26, 2017

    Report

    Report Number
    MW5070666
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 26, 2017
    Manufacturer
    AMBU INC.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A PRE-HOSPITAL CARDIAC ARREST. DURING THE CARDIAC ARREST A #5 LMA WAS PLACED AND USED AS THE PRIMARY AIRWAY. THE LMA WAS PLACED WITHOUT DIFFICULTY AND WAS SUCCESSFUL ON THE FIRST TRY. AFTER PLACING THE AIRWAY WE HAD BILATERAL CHEST RISE AND THE BVM HAD GOOD COMPLIANCE WHEN PROVIDING VENTILATIONS, EQUAL BREATH SOUNDS, AND WAVEFORM CAPNOGRAPHY READINGS. AFTER APPROXIMATELY 25-30 MINUTES WE NOTICED THAT THE BVM COMPLIANCE WAS DECREASING AND WE WERE NO LONGER HAVING ADEQUATE CHEST RISE OR CAPNOGRAPHY READING. THE BALLOON CUFF ON THE LMA WAS CHECKED AND IT WAS DISCOVERED THAT THE BALLOON HAD LEAKED AND WAS FLAT. MORE AIR WAS ADDED TO THE LMA AND CAPNOGRAPHY AND CHEST RISE IMPROVED. RECHECKING THE LMA SHORTLY AFTER, THE BALLOON WAS ONCE AGAIN FLAT. DURING THAT TIME ROSC WAS ACHIEVED AND TRANSPORT WAS INITIATED. TO DEAL WITH THE DEFLATING BALLOON AIR WAS ADDED REPEATEDLY TO MAINTAIN A SEAL DURING TRANSPORT. THE BALLOON AND CUFF ON THE LMA WAS NOT ASSESSED AFTER THE CALL AND THE ORIGIN OF THE FAILURE WAS NOT INSPECTED AFTER THE CALL AND PATIENT TURNOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447463 AMBU AURAGAIN LARYNGEAL MASK AIRWAY LARYNGEAL MASK AIRWAY CAE AMBU INC. 1812682

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention