BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY

    MDR report key: 2488997 · Received February 28, 2012

    Report

    Report Number
    2488997
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    January 18, 2012
    Report Date
    February 24, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DRAEGER VENTILATOR STOPPED WORKING, DISPLAYING DEVICE FAILURE 3. WHEN VENT ALARMED, PATIENT WAS MANUALLY BAGGED WITHOUT COMPROMISE. VENT SWITCHED OUT WITHOUT COMPROMISE. NO HARM TO PATIENT.======================MANUFACTURER RESPONSE FOR DRAEGER VENTILATOR (PER SITE REPORTER).======================AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA INFINITY VENTILATOR CBK DRAEGER MEDICAL GMBH V500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR