BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA DIAMOND

    MDR report key: 3231283 · Received July 11, 2013

    Report

    Report Number
    MW5030884
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 11, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VENT STARTED SMELLING LIKE FIRE WITHOUT ANY FIRE OR SMOKE. REMOVED FROM PT IMMEDIATELY AND SEQUESTERED. VENT SENT OUT (B)(6) 2013 BACK TO MANUFACTURER, SO THEIR ENGINEERS CAN REVIEW THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321235 VELA DIAMOND VENTILATOR CBK CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR