BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS VELA DIAMOND

    MDR report key: 4080802 · Received September 5, 2014

    Report

    Report Number
    MW5038120
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 5, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR ALARMING - VENTILATOR MALFUNCTION WITH "INOP (INOPERABLE) ERROR. MOST RECENT PREVENTATIVE MAINTENANCE CHECK DONE FOR THIS PIECE OF EQUIPMENT WAS (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543273 VIASYS VELA DIAMOND VENTILATOR CBK CAREFUSION 16532-00

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR