BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURA 40 REUSABLE

    MDR report key: 12142055 · Received July 9, 2021

    Report

    Report Number
    3003256355-2018-00001
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 13, 2018
    Report Date
    July 10, 2018
    Manufacturer
    BESMED HEALTH BUSINESS CORPORATION
    Product Code
    CAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLIER IMPLEMENTED 100% INSPECTION IN REFERENCE TO TRIMMING. MANUFACTURE INSTRUCTION FOR USE FOR FUNCTIONAL TESTING PRIOR TO DEVICE USE WAS NOT FOLLOWED BY THE USER. THIS MDR IS RESUBMITTED AGAIN AS IT WAS IDENTIFIED THAT ORIGINAL SUBMISSION HAD NOT BEEN SUCCESSFULLY LOADED INTO THE FDA DATABASE DUE TO MISSING EVENT CODE AND EXCEEDED CHARACTERS. INITIAL MDR WAS SUBMITTED AS JOINT REPORT FOR MANUFACTURER AND INITIAL IMPORTER. THE INITIAL MDR OF THIS INCIDENT WAS SUBMITTED TO THE FDA WITHIN THE ORIGINAL REPORTING DEADLINE. THIS SUBMISSION REPRESENTS A RELOAD OF DATA TO ENSURE CORRECT UPLOAD TO THE FDA DATABASE.

    Description of Event or Problem · 1

    THE NEW LARYNGEAL MASK WAS INSERTED INTO A PATIENT, THERE WAS NO HOLE IN THE TUBING FOR THE OXYGEN AND SEVOFLURANE TO ENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044771 AURA 40 REUSABLE LARYNGEAL MASK CAE BESMED HEALTH BUSINESS CORPORATION 703F154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention