BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERFREE AIRWAY MANAGEMENT SYSTEM (AMS)

    MDR report key: 10634730 · Received October 6, 2020

    Report

    Report Number
    10634730
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    August 19, 2020
    Report Date
    August 21, 2020
    Manufacturer
    SOMMETRICS
    Product Code
    PMB
    UDI-DI
    00851167007001
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN AIRWAY POSITIONING DEVICE, AERFREE AIRWAY MANAGEMENT SYSTEM (AMS), WAS APPLIED TO THE PT'S NECK AND THEN CONNECTED TO SUCTION. AT END OF PROCEDURE, THE DEVICE WAS REMOVED, AND BLISTERS WERE NOTED AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101919 AERFREE AIRWAY MANAGEMENT SYSTEM (AMS) EXTERNAL AIRWAY PMB SOMMETRICS 30-5001 120426(1) 00851167007001

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Other