BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP VISION

    MDR report key: 3171893 · Received May 29, 2013

    Report

    Report Number
    3171893
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 16, 2013
    Report Date
    May 29, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO CHANGE THE MODE ON THE BIPAP ALREADY IN USE BY THE PATIENT. THE MACHINE WOULD NOT ALLOW THE CHANGE TO BE MADE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT WAS ALREADY IN DISTRESS AND THE PRACTITONER ATTEMPTED TO CHANGE THE MODE ON THE BIPAP MACHINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234396 BIPAP VISION ATTACHMENT, BREATHING, POSITIVE AND EXPIRATORY BYE RESPIRONICS, INC. 582059 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR