BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3871151 · Received April 14, 2014

    Report

    Report Number
    8020893-2014-00907
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. IN THE EVENT THAT ADD'L INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A REPORT REC'D FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A GRAPHICAL USER INTERFACE (GUI) COMMUNICATION ALERT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228196 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1