BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2934368 · Received January 11, 2013

    Report

    Report Number
    8020893-2013-00094
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCORE
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR WAS INOPERABLE WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE (GUI) PCB. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) UPDATED THE SOFTWARE AND CONDUCTED FINAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19271 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCORE 840

    Patients

    Seq Age Sex Outcome Treatment
    1