BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER VENTILATOR

    MDR report key: 67234 · Received January 6, 1997

    Report

    Report Number
    67234
    Event Type
    Injury
    Date Received
    January 6, 1997
    Date of Event
    November 8, 1996
    Report Date
    November 21, 1996
    Manufacturer
    DRAGER INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AFTER EACH SUCTIONING, THE PT WITH 100% OXYGEN SUCTION ON, VENTILATOR STOPS CYCLING. NECESSARY TO MANUALLY VENTILATE. AFTER RESETTING, THE MACHINE STARTS TO FUNCTION AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER VENTILATOR ADULT VENTILATOR CBK DRAGER INC. EVITA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention