BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3901906 · Received May 7, 2014

    Report

    Report Number
    8020893-2014-01093
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 11, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DECLINED SERVICE ON THE DEVICE; THEREFORE, THE EVENT COULD NOT BE VERIFIED. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM THE USA WITH INFO THAT AN 840 VENTILATOR GRAPHIC USER INTERFACE (GUI) WAS INOPERATIVE. THE DEVICE WAS NOT BEING USED ON A PATIENT WHEN EVENT OCCURRED. THE DATE OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276846 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1