BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIFLOW

    MDR report key: 1952323 · Received December 22, 2010

    Report

    Report Number
    1952323
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    November 27, 2010
    Report Date
    December 22, 2010
    Manufacturer
    FISCHER AND PAYKEL HEALTHCARE LIMITED
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING TRIALED ON OPTI-FLOW. THE PATIENT WAS FOUND UNRESPONSIVE WITH THE MASK LYING ON THEIR CHEST.====================== HEALTH PROFESSIONAL'S IMPRESSION======================LACK OF ALARM SYSTEM TO IDENTIFY DISPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLOW OPTIFLOW BZD FISCHER AND PAYKEL HEALTHCARE LIMITED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death NO OTHER THERAPIES