BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3810714 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-10000
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR CUSTOMER SUPPORT ENGINEER (CSE) REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) AND DOWNLOADED REV AK SOFTWARE. THE DEVICE PASSED ALL TESTS PER THE SERVICE MANUAL. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA INDICATING THAT DURING INSTALLATION OF REV AK SOFTWARE BY A THIRD PARTY TECHNICIAN, THE SCREEN TURNED RED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169151 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1