BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6535666 · Received May 1, 2017

    Report

    Report Number
    2021710-2017-05867
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    November 16, 2014
    Report Date
    May 1, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CUSTOMER INFORMATION WAS PROVIDED THROUGH THE RECEIVED MEDWATCH SO NO CUSTOMER CONTACT ATTEMPTS OR SAMPLE EVALUATION CAN BE PERFORMED. IT WAS NOTED THAT ON THE RECEIVED USER FACILITY SUBMITTED MEDWATCH THAT THERE WERE SEVERAL MISSPELLING OR INACCURATE INFORMATION: DEVICE IS REPORTED AS THE "VELE" VENTILATOR, IN WHICH NO PRODUCT PRODUCED BY CAREFUSION EXISTS. IT IS ASSUMED THAT THE CUSTOMER IS REFERRING TO THE "VELA" VENTILATOR. THE DEVICE MANUFACTURER ADDRESS WAS LISTED AS "(B)(4)", IN WHICH NO FACILITY OPERATED BY CAREFUSION EXISTS FOR RESPIRATORY PRODUCTS. IT IS ASSUMED THAT THE CUSTOMER IS REFERRING TO A CAREFUSION FACILITY IN "(B)(4)" THAT IS DOES NOT DIRECTLY PERFORM BUSINESS RELATED TO RESPIRATORY PRODUCTS. THERE IS CURRENTLY NO INFORMATION TO INDICATE THAT THEY WERE NOTIFIED OF THIS USER FACILITY SUBMITTED MEDWATCH. THE CUSTOMER SELECTED THE PRODUCT CODE OF "ONZ", WHICH WOULD BE INCORRECT AS THE VELA VENTILATOR IS REGISTERED AS A "CBK". CAREFUSION DOES NOT MANUFACTURE NOR DISTRIBUTE ANY PRODUCTS WITH THE "ONZ" PRODUCT CODE. NO SERIAL NUMBER WAS PROVIDED BY THE MEDWATCH. A KEYWORD AND DATE SEARCH WAS UNABLE TO FIND ANY DOCUMENTED COMPLAINTS MATCHING THE DESCRIPTION PROVIDED THROUGH THE RECEIVED MEDWATCH. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FDA INSPECTOR PROVIDED A USER FACILITY REPORTED MEDWATCH (MW5039300) THAT STATES: "AT 930AM ON ((B)(6) 2014) 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
    314721 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA COMP D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention