BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELE VENTILATOR DIAMOND SERIES

    MDR report key: 4284344 · Received November 21, 2014

    Report

    Report Number
    MW5039300
    Event Type
    Injury
    Date Received
    November 21, 2014
    Date of Event
    November 16, 2014
    Report Date
    November 21, 2014
    Manufacturer
    CARFUSION
    Product Code
    ONZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT 930AM ON (B)(6) WHILE CNA IN ROOM, VENT SCREEN READ "PATIENT SET UP MODE" (VENTILATOR NOT DELIVERING ANYTHING). RT IMMEDIATELY CAME IN ROOM AND SELECTED "RESUME CURRENT SETTINGS", AND VENT WAS RUNNING OK. OXYGEN STATS NEVER FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756818 VELE VENTILATOR DIAMOND SERIES MECHANICAL VENTILATOR ONZ CARFUSION VELE COMP D

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention