BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY

    MDR report key: 3010462 · Received March 16, 2013

    Report

    Report Number
    3010462
    Event Type
    Malfunction
    Date Received
    March 16, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 11, 2013
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRAGER VENTILATOR READING INTERNAL POWER FAILURE. PATIENT WAS STILL BEING VENTILATED SUCCESSFULLY. VENTILATOR SWITCHED OUT FOR ANOTHER ONE. VENT TAKEN TO RESPIRATORY HOLDING AREA TO BE ASSESSED.DRAGER TECHNICAL SERVICE REPRESENTATIVE DETERMINED IT WAS DUE TO INCOMPATIBLE DRIVER AND RELOADED SOFTWARE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MAINTAIN PATIENT AIRWAY, BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111081 EVITA INFINITY VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER MEDICAL, INC. EVITA INFINITY V500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR