BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP VISION

    MDR report key: 3000934 · Received March 6, 2013

    Report

    Report Number
    2518422-2013-00373
    Event Type
    Death
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 20, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    MNT
    PMA / PMN Number
    K982454
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR REC'D INFO ALLEGING A PT EXPIRED WHILE USING A BIPAP VISION. THE DEVICE IS NOT BEING RELEASED TO THE MFR FOR EVALUATION AT THIS TIME. A FOLLOW UP REPORT WILL BE FILED WHEN THE MFR HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94861 BIPAP VISION VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS INC. 582059 582059

    Patients

    Seq Age Sex Outcome Treatment
    1 Death