BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6142161 · Received December 2, 2016

    Report

    Report Number
    2021710-2016-04960
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 2, 2016
    Report Date
    April 14, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT FRONT PANEL ASSEMBLY FOR INVESTIGATION. AN INVESTIGATION WAS PERFORMED AND IDENTIFIED THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO FLUID INGRESS WITHIN THE ASSEMBLY. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN CAREFUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S TOUCHSCREEN WAS NOT WORKING AS THERE WAS DELAMINATION AT THE BOTTOM RIGHT HAND CORNER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793956 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1