BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-60 BIPAP

    MDR report key: 3933952 · Received June 30, 2014

    Report

    Report Number
    3933952
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    October 26, 2013
    Report Date
    October 30, 2013
    Manufacturer
    RESPIRONICS
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    DEVICE ALARMED "NO OXYGEN" AND PATIENT DESATURATED FROM 94 TO 83. PATIENT SWITCHED TO VISION BIPAP AND MAINTAINED OXYGEN SATURATIONS AFTERWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378631 V-60 BIPAP VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY MNT RESPIRONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR