BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3201376 · Received June 27, 2013

    Report

    Report Number
    8020893-2013-01402
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 28, 2013
    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
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT DUE TO AN 840 VENTILATOR MALFUNCTION, THE PT WAS PLACED ON ANOTHER VENTILATOR. THE CUSTOMER REPORTED TO HAVE REPLACED THE BREATH DELIVERY UNIT (BDU) PCB. COVIDIEN UPLOADED TO CURRENT SOFTWARE VERSION ONLY. THE UNIT PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292921 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention