BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3181962 · Received June 17, 2013

    Report

    Report Number
    8020893-2013-01334
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR WAS INOPERABLE. THERE WAS NO PT INVOLVEMENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE (GUI) CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO SVC THE DEVICE. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS ONLY AUTHORIZED TO UPGRADE THE SOFTWARE TO THE CURRENT VERSION. THE UNIT PASSED EXTENDED SELF-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274572 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1