BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 2190149 · Received August 1, 2011

    Report

    Report Number
    2190149
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 3, 2011
    Report Date
    August 1, 2011
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL LIGHTS FLICKERED AND FAMILY MEMBER CALLED STAFF TO PATIENT'S ROOM AND REPORTED THAT THE VENTILATOR NOT WORKING. RESPIRATORY THERAPIST FOUND VENTILATOR COMPLETELY SHUT DOWN AND THE SCREEN BLACK. PATIENT WAS "BAGGED" UNTIL A SECOND VENTILATOR WAS SET UP FOR THE PT. THE AVEA VENTILATORS ARE KEPT PLUGGED INTO AN AC OUTLET AT ALL TIMES. THE BATTERIES ARE CHANGED EVERY TWO YEARS AS PER OEM MAINTENANCE REQUIREMENTS AND THE BATTERIES ON THE REPORTED DEVICE WERE LAST CHANGED SEPTEMBER 2010. ======================MANUFACTURER RESPONSE FOR VENTILATOR, (PER SITE REPORTER)======================ORIGINAL EQUIPMENT MANUFACTURER (OEM) WAS CONTACTED AND PERFORMED A COMPLETE DIAGNOSTIC TEST OF EQUIPMENT. FOUND THE BATTERY HAD A MAXIMUN RUN TIME OF 20 MINUTES. NO OTHER FAILURES NOTED. THE AVEA BATTERY WAS REPLACED AND THE UNIT CHECKED OUT PER OEM SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 207, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR