BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU AURASTRAIGHT SILICONE

    MDR report key: 9314545 · Received November 13, 2019

    Report

    Report Number
    9314545
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    September 27, 2019
    Report Date
    October 15, 2019
    Manufacturer
    BESMED HEALTH BUSINESS CORPORATION
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST ATTEMPTED TO PLACE LARYNGEAL MASK AIRWAY (LMA) X3 (AMBU AURASTRAIGHT SILICONE SINGLE USE LARYNGEAL MASK) WITH DIFFICULTY AND WITHOUT SUCCESS. LMA OF VARIOUS SIZES WOULD NOT GO DOWN OR STAY IN THE PROPER PLACE. PATIENT HAD MODERATE BLOODY SECRETIONS. ANESTHESIA'S PLAN FOR GENERAL ANESTHESIA CONVERTED TO MONITORED ANESTHESIA CARE. MAC SEDATION USED FOR PROCEDURE INSTEAD OF PLANNED GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111446 AMBU AURASTRAIGHT SILICONE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY CAE BESMED HEALTH BUSINESS CORPORATION 342300000, 342500000, 342400000

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA