BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3893946 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01418
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE SERVICE REPAIR STATUS IS UNAVAILABLE, AND INVESTIGATION IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, AN 840 VENTILATOR GRAPHIC USER INTERFACE (GUI) FAILED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346128 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention