BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTILATOR, CONTINUOUS MINIMAL VENTILATORY SUPPORT, FACILITY

    MDR report key: 2214058 · Received July 19, 2011

    Report

    Report Number
    2518422-2011-00081
    Event Type
    Other
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K982454
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION THAT A BIPAP VISION'S OXYGEN CONCENTRATION COULD NOT BE ADJUSTED. THE OXYGEN CONCENTRATION WAS SET AT 100% AND ALLEGEDLY DECREASED TO 21% WHILE ON A PATIENT. THE PATIENT WAS ON THE DEVICE FOR FIVE MINUTES AND REQUIRED INTUBATION AND WAS PLACED ON A MECHANICAL VENTILATOR. THE MANUFACTURER HAS NOT COMPLETED THE INVESTIGATION INTO THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS MINIMAL VENTILATORY SUPPORT, FACILITY BIPAP VISION MNT RESPIRONICS, INC. 582059

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention