BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3962669 · Received June 18, 2014

    Report

    Report Number
    8020893-2014-01456
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 23, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) ASSISTED THE USER FACILITY WITH TROUBLESHOOTING THE DEVICE VIA PHONE. THE CSE RECOMMENDED REPLACING THE GUI REAL TIME CLOCK. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A DEVICE ALERT WHICH RENDERED THE GRAPHICAL USER INTERFACE (GUI) INOPERABLE. THERE WAS NO PT INVOLVEMENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356697 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1